June 14, 2018 presentation to the San Diego Regulatory Affairs Network (SDRAN) Regulatory Affairs Certification (RAC) Review Course on the basics of FDA regulation of generic drugs and biosimilars.
FDA Inspections: Handling the Consequences -- or Understanding How Ugly It C...Michael Swit
Presentation to the MAGI Clinical Research Conference – 2018 East, given on May 22, 2018 in Arlington, Virginia, and focusing on the collateral consequences of negative FDA inspections in the clinical research arena
February 7, 2017
Many of today’s important medications are biological products made from living organisms, manufactured through biotechnology, derived from natural sources, or produced synthetically. Biosimilars are a type of biological product approved by FDA on the basis of being highly similar to an already approved biological reference product.
This panel of experts discussed the current state of biosimilars in the healthcare ecosystem and what comes next from a technical and legal perspective. Topics included how the next generation of biosimilars could improve patient access to standard-of-care therapies, the concept of “biobetters,” economic and intellectual property considerations, and policy approaches to support existing and future biosimilars.
Learn more on our website: http://petrieflom.law.harvard.edu/events/details/looking-forward
Presentation at the Biosimilars and Follow-On Biologics 2014 Americas Conference, sponsored by Paradigm Global Events, February 12, 2014. Presentation focused on:
•Interchangeability
•State Substitution Laws
•Naming
•Risk Evaluation & Mitigation Strategies (REMS) and Their Impact on Biosimilars
•Where FDA Stands on Biosimilars
Update on U.S. Regulation of BiosimilarsMichael Swit
This document summarizes key issues regarding U.S. regulation of biosimilars, including the filing of the first biosimilar applications, requirements for demonstrating interchangeability, state substitution laws, challenges around naming conventions, and arguments on both sides of the naming debate. Industry is pursuing clinical trial designs aimed at demonstrating interchangeability, while FDA guidance is pending and naming remains controversial with pros arguing it ensures traceability and cons arguing it reduces biosimilar uptake.
Latest Developments in and the Future of the Regulatory Landscape for Approv...Michael Swit
Presentation on "Latest Developments in and the Future of the
Regulatory Landscape for Approving Treatments
for Orphan and Rare Diseases," given at the Orphan Drugs & Rare Diseases -- 2018 Americas West Coast Conference.
June 25, 2018. San Diego, CA.
This document discusses brand name drugs and generic drugs. It provides definitions and examples to compare the two. Brand name drugs are invented by pharmaceutical companies, while generic drugs have the same active ingredients but can differ in inactive ingredients and formulation. Generic drugs are approved through an Abbreviated New Drug Application to the FDA which requires bioequivalence testing. The document outlines the FDA approval process and regulations for both brand name and generic drugs to be equivalent in quality, safety and efficacy. It also discusses factors like research costs that contribute to higher prices of brand name drugs compared to generics.
Hi all, with the rigorous secondary research for almost one month helped me to understand basic things about biosimilars and made me do this presentation. Hope u will appreciate it while going through it. thanks.
If anyone in need of this presentation, pls.put ur emial ID in comment box. will be sharing. and please share your thoughts about the presentation. i will be more thankful.
Generic drugs contain the same active ingredients and are equivalent to their brand name counterparts. They are allowed for sale after the original drug patent expires. Generics are usually cheaper than brands because generic manufacturers don't have the same research and development costs as brand manufacturers. The FDA requires generics to have the same clinical effects as their brand versions.
FDA Inspections: Handling the Consequences -- or Understanding How Ugly It C...Michael Swit
Presentation to the MAGI Clinical Research Conference – 2018 East, given on May 22, 2018 in Arlington, Virginia, and focusing on the collateral consequences of negative FDA inspections in the clinical research arena
February 7, 2017
Many of today’s important medications are biological products made from living organisms, manufactured through biotechnology, derived from natural sources, or produced synthetically. Biosimilars are a type of biological product approved by FDA on the basis of being highly similar to an already approved biological reference product.
This panel of experts discussed the current state of biosimilars in the healthcare ecosystem and what comes next from a technical and legal perspective. Topics included how the next generation of biosimilars could improve patient access to standard-of-care therapies, the concept of “biobetters,” economic and intellectual property considerations, and policy approaches to support existing and future biosimilars.
Learn more on our website: http://petrieflom.law.harvard.edu/events/details/looking-forward
Presentation at the Biosimilars and Follow-On Biologics 2014 Americas Conference, sponsored by Paradigm Global Events, February 12, 2014. Presentation focused on:
•Interchangeability
•State Substitution Laws
•Naming
•Risk Evaluation & Mitigation Strategies (REMS) and Their Impact on Biosimilars
•Where FDA Stands on Biosimilars
Update on U.S. Regulation of BiosimilarsMichael Swit
This document summarizes key issues regarding U.S. regulation of biosimilars, including the filing of the first biosimilar applications, requirements for demonstrating interchangeability, state substitution laws, challenges around naming conventions, and arguments on both sides of the naming debate. Industry is pursuing clinical trial designs aimed at demonstrating interchangeability, while FDA guidance is pending and naming remains controversial with pros arguing it ensures traceability and cons arguing it reduces biosimilar uptake.
Latest Developments in and the Future of the Regulatory Landscape for Approv...Michael Swit
Presentation on "Latest Developments in and the Future of the
Regulatory Landscape for Approving Treatments
for Orphan and Rare Diseases," given at the Orphan Drugs & Rare Diseases -- 2018 Americas West Coast Conference.
June 25, 2018. San Diego, CA.
This document discusses brand name drugs and generic drugs. It provides definitions and examples to compare the two. Brand name drugs are invented by pharmaceutical companies, while generic drugs have the same active ingredients but can differ in inactive ingredients and formulation. Generic drugs are approved through an Abbreviated New Drug Application to the FDA which requires bioequivalence testing. The document outlines the FDA approval process and regulations for both brand name and generic drugs to be equivalent in quality, safety and efficacy. It also discusses factors like research costs that contribute to higher prices of brand name drugs compared to generics.
Hi all, with the rigorous secondary research for almost one month helped me to understand basic things about biosimilars and made me do this presentation. Hope u will appreciate it while going through it. thanks.
If anyone in need of this presentation, pls.put ur emial ID in comment box. will be sharing. and please share your thoughts about the presentation. i will be more thankful.
Generic drugs contain the same active ingredients and are equivalent to their brand name counterparts. They are allowed for sale after the original drug patent expires. Generics are usually cheaper than brands because generic manufacturers don't have the same research and development costs as brand manufacturers. The FDA requires generics to have the same clinical effects as their brand versions.
The document discusses generic drugs and biosimilars. It provides biographical information about the speaker and outlines key questions about generics that will be addressed. Generic drugs are defined as comparable but not identical to brand name drugs in dosage, strength, quality and performance. Biosimilars are similar to biologic drugs but require more extensive testing than generics due to their complex nature. The market for generic drugs is large and growing, particularly in emerging markets, as major drugs lose patent protection.
This document provides an overview of biosimilars. It discusses that biosimilars are similar versions of biologic drugs that are set to lose patent protection. This presents both opportunities to make cheaper biologics to increase access, as well as regulatory challenges to demonstrate similarity. The global biosimilars market is growing, driven by both developed and emerging markets. India is emerging as a key player, with companies developing biosimilars for both domestic and export markets. However, hurdles remain around establishing clear regulatory pathways and demonstrating similarity to reference biologics.
Presentation to the IBC 9th Annual Conference on Generic Drugs, September 1999, in Washington, D.C., with an emphasis on reviewing how brand name drug companies have tried to challenge the approval of generic versions of their drug products.
1.Patients have poor or no knowledge of the price variations among branded and generic medicines, and leave the choice of the medicine to the doctor.
2.The government must take up generic promotional schemes, general awareness programs on quality of generics to build confidence among prescribers, pharmacists, and consumers.
This document discusses biosimilars, which are biologic drugs that are similar but not identical to already approved biologic drugs (reference biologics). It provides background on biologics and biosimilars, including that biosimilars take longer and cost less to develop than original biologics. Several regulatory issues for biosimilars are also discussed, such as naming, substitution, approval of indications, and reimbursement. The US recently approved its first biosimilar, but still lags behind Europe in approving and using biosimilars.
This document discusses generics drugs and provides an overview of their history, types, current state, and future prospects. It notes that generics are copies of branded drugs that are cheaper due to not having research and development costs. The 1984 Hatch-Waxman Act created an abbreviated approval pathway for generics in the US. Today, generics make up a large and growing portion of the global drug market, projected to reach $380 billion by 2021. However, generics still face challenges such as patent litigation from brand manufacturers and price erosion as multiple generics enter the market.
Please share this slideshow with anyone who may be interested!
Watch all our webinars: https://www.youtube.com/playlist?list=PL4dDQscmFYu_ezxuxnAE61hx4JlqAKXpR
In this webinar:
● Discussion on biologics, including an explanation of the high level of precision that is required to produce a consistent biological product each time.
● Discussion on the growing interest in biosimilars, followed by what we can learn from Europe’s experience.
● Health Canada’s position on biosimilars, discussion on key issues surrounding biosimilars relevant to the Canadian market.
● The importance of patient safety and patient choice.
View the video: https://youtu.be/h3Ap6HoiSC8
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Facebook - https://www.facebook.com/CanadianSurvivorNet
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This document discusses the regulatory requirements for clinical development of biosimilars in India. It provides an overview of the applicable regulations, guidelines, and authorities overseeing clinical trials. The key principles for developing biosimilars are to demonstrate comparability to the reference biologic through a stepwise characterization and clinical development program involving pharmacokinetic, pharmacodynamic, and confirmatory safety and efficacy studies. Post-marketing requirements include pharmacovigilance plans and potential post-marketing studies to further evaluate safety and immunogenicity.
The document discusses generic medicines and their evolution. It notes that generic medicines provide significant economic advantages to consumers and the pharmaceutical industry by decreasing drug prices after brand name patents expire. Approximately 50% of prescriptions in many countries are now filled by lower cost generic drugs. The generic drug market in India, which supplies over 30% of the global generic market, is growing substantially and expected to reach $72 billion by 2020. While generic drugs must demonstrate bioequivalence to the brand name version, they provide significant cost savings over branded drugs for both consumers and healthcare systems.
The document discusses the generic drug development process and the Hatch-Waxman Act. It defines generic drugs as being identical to brand name drugs in active ingredients, dosage form, quality and therapeutic effects. The generic drug approval process involves submitting an Abbreviated New Drug Application to the FDA that demonstrates bioequivalence to the brand name drug. The Hatch-Waxman Act established the modern system of generic drug regulation, providing incentives for generic drugs to gain FDA approval and compensating brand name drugs for patent time lost during regulatory review.
Dialogue with Canada’s leading regulatory and assessment experts: Health Canada Bureau of Biologics and Genetic Therapies (BGTD) and Canadian Agency for Drugs and Technologies in Health (CADTH)
Date: June 29, 2016
Time: 1:00pm to 3:00pm EST
- Biosimilars are biologic medical products that are similar but not identical copies of original biologic drugs. They are developed when the patent expires on the original product.
- Regulatory agencies have stringent approval criteria for biosimilars to demonstrate similar quality, safety and efficacy as the reference product. Clinical trials must show comparable pharmacokinetics, pharmacodynamics and immunogenicity.
- While biosimilars increase access and lower costs, they are not generic copies and have unique safety profiles. Automatic substitution is not appropriate and unique nonproprietary names and labeling is required to facilitate pharmacovigilance.
This document outlines topics related to compliance and intellectual property in the pharmaceutical industry. It discusses the FDA structure, drug development process, and key issues that affect IP lawyers, such as advertising, feedback loops during drug development, service agreements, drug naming, patent extensions and exclusivity, lifecycle management, and generic drug approval challenges. The document provides an overview of these topics at a high level and is intended to familiarize IP lawyers with compliance and regulatory considerations.
The document discusses the Abbreviated New Drug Application (ANDA) process for generic drugs in the United States. An ANDA is a request to the FDA to manufacture and market a generic drug, and is abbreviated since it does not require clinical trials like a New Drug Application. The key points covered include basic generic drug requirements, the objective of reducing drug costs, comparisons between innovator and generic drugs and between NDAs and ANDAs, the Hatch-Waxman Act of 1984 which established the ANDA pathway, patent certification requirements, and an overview of the ANDA review process.
Bio similar- An opportunities or challenge for Indian Company Debashish Kar
1. The global biosimilars market is expected to grow significantly in the coming years due to various drivers such as patent expiries of major biologics and increasing cost containment pressures.
2. Indian companies are well positioned in the biosimilars space due to their established low-cost manufacturing capabilities and expertise in biologics. Key players in India include Dr. Reddy's, Biocon, Cipla and Intas.
3. Developing biosimilars presents several challenges including high development costs, complex clinical trials and unclear regulatory guidelines. Indian companies strategy involves partnerships for cost-effective development and leveraging domestic capabilities and emerging markets for growth.
This document provides an overview of biosimilars and their regulatory framework. It begins with definitions of biologics and biosimilars. Biosimilars are highly similar versions of approved biologics whose patents have expired. The development of biosimilars is unique compared to small molecule generics due to the complex nature of biologics. The document then discusses issues with biosimilars including potential efficacy, safety and substitution concerns. Finally, it provides details on the regulatory frameworks and guidelines established by organizations like WHO, EU, US and India to help facilitate the development and approval of biosimilars.
This document discusses generic drugs and the FDA approval process. It aims to dispel myths about generic drugs by explaining that generics are as safe and effective as brand name drugs and must meet the same standards. The FDA reviews generics rigorously to confirm quality, safety and effectiveness. Further, the document outlines efforts by the FDA and government to increase availability and affordability of generic drugs.
Biosimilars are biopharmaceutical drugs that are similar to an original biologic drug, but are manufactured when the original drug's patent expires. Biosimilars must demonstrate similarity to the original product in terms of quality, safety and efficacy. India has advantages in manufacturing biosimilars due to lower costs and skilled workforce. Major Indian companies are developing biosimilars and targeting both domestic and international markets like the US and EU. Regulatory authorities in India approve and regulate biosimilars to ensure their safety and efficacy.
June 24, 2015 Presentation to the Regulatory Affairs Certification (RAC) Test Review Course sponsored by the San Diego Regulatory Affairs Network, with a focus on regulation of ANDAs, OTC drugs, and Orphan Drugs, covering these issues relating to generic drugs:
♦ Basics
♦ User Fees
♦ Power
♦ Addressing Abuses – by Rule & Statute
♦ Biosimilars – Basics of New Law
This document summarizes a presentation about FDA regulation of biosimilars. It discusses how biosimilars differ from traditional generics due to biologics being more complex molecules than small molecule drugs. It outlines the key provisions of the Biologics Price Competition and Innovation Act of 2009, including requirements for biosimilar applications such as analytical, animal and clinical studies demonstrating biosimilarity to the reference product. It also discusses requirements for interchangeability and other miscellaneous rules regarding biosimilar approval pathways.
What’s In a Name? FDA and Non-Proprietary Names for Biologics/BiosimilarsMichael Swit
April 20, 2018 Presentation to the 11th Biosimilars & Follow-On Biologics 2018 Americas conference on FDA's Policy on Non-proprietary names for Biosimilars
The document discusses generic drugs and biosimilars. It provides biographical information about the speaker and outlines key questions about generics that will be addressed. Generic drugs are defined as comparable but not identical to brand name drugs in dosage, strength, quality and performance. Biosimilars are similar to biologic drugs but require more extensive testing than generics due to their complex nature. The market for generic drugs is large and growing, particularly in emerging markets, as major drugs lose patent protection.
This document provides an overview of biosimilars. It discusses that biosimilars are similar versions of biologic drugs that are set to lose patent protection. This presents both opportunities to make cheaper biologics to increase access, as well as regulatory challenges to demonstrate similarity. The global biosimilars market is growing, driven by both developed and emerging markets. India is emerging as a key player, with companies developing biosimilars for both domestic and export markets. However, hurdles remain around establishing clear regulatory pathways and demonstrating similarity to reference biologics.
Presentation to the IBC 9th Annual Conference on Generic Drugs, September 1999, in Washington, D.C., with an emphasis on reviewing how brand name drug companies have tried to challenge the approval of generic versions of their drug products.
1.Patients have poor or no knowledge of the price variations among branded and generic medicines, and leave the choice of the medicine to the doctor.
2.The government must take up generic promotional schemes, general awareness programs on quality of generics to build confidence among prescribers, pharmacists, and consumers.
This document discusses biosimilars, which are biologic drugs that are similar but not identical to already approved biologic drugs (reference biologics). It provides background on biologics and biosimilars, including that biosimilars take longer and cost less to develop than original biologics. Several regulatory issues for biosimilars are also discussed, such as naming, substitution, approval of indications, and reimbursement. The US recently approved its first biosimilar, but still lags behind Europe in approving and using biosimilars.
This document discusses generics drugs and provides an overview of their history, types, current state, and future prospects. It notes that generics are copies of branded drugs that are cheaper due to not having research and development costs. The 1984 Hatch-Waxman Act created an abbreviated approval pathway for generics in the US. Today, generics make up a large and growing portion of the global drug market, projected to reach $380 billion by 2021. However, generics still face challenges such as patent litigation from brand manufacturers and price erosion as multiple generics enter the market.
Please share this slideshow with anyone who may be interested!
Watch all our webinars: https://www.youtube.com/playlist?list=PL4dDQscmFYu_ezxuxnAE61hx4JlqAKXpR
In this webinar:
● Discussion on biologics, including an explanation of the high level of precision that is required to produce a consistent biological product each time.
● Discussion on the growing interest in biosimilars, followed by what we can learn from Europe’s experience.
● Health Canada’s position on biosimilars, discussion on key issues surrounding biosimilars relevant to the Canadian market.
● The importance of patient safety and patient choice.
View the video: https://youtu.be/h3Ap6HoiSC8
Follow our social media accounts:
Twitter - https://twitter.com/survivornetca
Facebook - https://www.facebook.com/CanadianSurvivorNet
Pinterest - https://www.pinterest.com/survivornetwork
YouTube - https://www.youtube.com/user/Survivornetca
This document discusses the regulatory requirements for clinical development of biosimilars in India. It provides an overview of the applicable regulations, guidelines, and authorities overseeing clinical trials. The key principles for developing biosimilars are to demonstrate comparability to the reference biologic through a stepwise characterization and clinical development program involving pharmacokinetic, pharmacodynamic, and confirmatory safety and efficacy studies. Post-marketing requirements include pharmacovigilance plans and potential post-marketing studies to further evaluate safety and immunogenicity.
The document discusses generic medicines and their evolution. It notes that generic medicines provide significant economic advantages to consumers and the pharmaceutical industry by decreasing drug prices after brand name patents expire. Approximately 50% of prescriptions in many countries are now filled by lower cost generic drugs. The generic drug market in India, which supplies over 30% of the global generic market, is growing substantially and expected to reach $72 billion by 2020. While generic drugs must demonstrate bioequivalence to the brand name version, they provide significant cost savings over branded drugs for both consumers and healthcare systems.
The document discusses the generic drug development process and the Hatch-Waxman Act. It defines generic drugs as being identical to brand name drugs in active ingredients, dosage form, quality and therapeutic effects. The generic drug approval process involves submitting an Abbreviated New Drug Application to the FDA that demonstrates bioequivalence to the brand name drug. The Hatch-Waxman Act established the modern system of generic drug regulation, providing incentives for generic drugs to gain FDA approval and compensating brand name drugs for patent time lost during regulatory review.
Dialogue with Canada’s leading regulatory and assessment experts: Health Canada Bureau of Biologics and Genetic Therapies (BGTD) and Canadian Agency for Drugs and Technologies in Health (CADTH)
Date: June 29, 2016
Time: 1:00pm to 3:00pm EST
- Biosimilars are biologic medical products that are similar but not identical copies of original biologic drugs. They are developed when the patent expires on the original product.
- Regulatory agencies have stringent approval criteria for biosimilars to demonstrate similar quality, safety and efficacy as the reference product. Clinical trials must show comparable pharmacokinetics, pharmacodynamics and immunogenicity.
- While biosimilars increase access and lower costs, they are not generic copies and have unique safety profiles. Automatic substitution is not appropriate and unique nonproprietary names and labeling is required to facilitate pharmacovigilance.
This document outlines topics related to compliance and intellectual property in the pharmaceutical industry. It discusses the FDA structure, drug development process, and key issues that affect IP lawyers, such as advertising, feedback loops during drug development, service agreements, drug naming, patent extensions and exclusivity, lifecycle management, and generic drug approval challenges. The document provides an overview of these topics at a high level and is intended to familiarize IP lawyers with compliance and regulatory considerations.
The document discusses the Abbreviated New Drug Application (ANDA) process for generic drugs in the United States. An ANDA is a request to the FDA to manufacture and market a generic drug, and is abbreviated since it does not require clinical trials like a New Drug Application. The key points covered include basic generic drug requirements, the objective of reducing drug costs, comparisons between innovator and generic drugs and between NDAs and ANDAs, the Hatch-Waxman Act of 1984 which established the ANDA pathway, patent certification requirements, and an overview of the ANDA review process.
Bio similar- An opportunities or challenge for Indian Company Debashish Kar
1. The global biosimilars market is expected to grow significantly in the coming years due to various drivers such as patent expiries of major biologics and increasing cost containment pressures.
2. Indian companies are well positioned in the biosimilars space due to their established low-cost manufacturing capabilities and expertise in biologics. Key players in India include Dr. Reddy's, Biocon, Cipla and Intas.
3. Developing biosimilars presents several challenges including high development costs, complex clinical trials and unclear regulatory guidelines. Indian companies strategy involves partnerships for cost-effective development and leveraging domestic capabilities and emerging markets for growth.
This document provides an overview of biosimilars and their regulatory framework. It begins with definitions of biologics and biosimilars. Biosimilars are highly similar versions of approved biologics whose patents have expired. The development of biosimilars is unique compared to small molecule generics due to the complex nature of biologics. The document then discusses issues with biosimilars including potential efficacy, safety and substitution concerns. Finally, it provides details on the regulatory frameworks and guidelines established by organizations like WHO, EU, US and India to help facilitate the development and approval of biosimilars.
This document discusses generic drugs and the FDA approval process. It aims to dispel myths about generic drugs by explaining that generics are as safe and effective as brand name drugs and must meet the same standards. The FDA reviews generics rigorously to confirm quality, safety and effectiveness. Further, the document outlines efforts by the FDA and government to increase availability and affordability of generic drugs.
Biosimilars are biopharmaceutical drugs that are similar to an original biologic drug, but are manufactured when the original drug's patent expires. Biosimilars must demonstrate similarity to the original product in terms of quality, safety and efficacy. India has advantages in manufacturing biosimilars due to lower costs and skilled workforce. Major Indian companies are developing biosimilars and targeting both domestic and international markets like the US and EU. Regulatory authorities in India approve and regulate biosimilars to ensure their safety and efficacy.
June 24, 2015 Presentation to the Regulatory Affairs Certification (RAC) Test Review Course sponsored by the San Diego Regulatory Affairs Network, with a focus on regulation of ANDAs, OTC drugs, and Orphan Drugs, covering these issues relating to generic drugs:
♦ Basics
♦ User Fees
♦ Power
♦ Addressing Abuses – by Rule & Statute
♦ Biosimilars – Basics of New Law
This document summarizes a presentation about FDA regulation of biosimilars. It discusses how biosimilars differ from traditional generics due to biologics being more complex molecules than small molecule drugs. It outlines the key provisions of the Biologics Price Competition and Innovation Act of 2009, including requirements for biosimilar applications such as analytical, animal and clinical studies demonstrating biosimilarity to the reference product. It also discusses requirements for interchangeability and other miscellaneous rules regarding biosimilar approval pathways.
What’s In a Name? FDA and Non-Proprietary Names for Biologics/BiosimilarsMichael Swit
April 20, 2018 Presentation to the 11th Biosimilars & Follow-On Biologics 2018 Americas conference on FDA's Policy on Non-proprietary names for Biosimilars
The document provides an overview of the Waxman-Hatch Act of 1984, which established the modern generic drug approval pathway in the United States. It discusses the reasons for its creation, key provisions such as bioequivalence standards and patent certification requirements, and subsequent amendments. The Act sought to balance increased availability of low-cost generic drugs with incentives for continued pharmaceutical innovation.
Introduction to the Legal Basis for Generic Drug ApprovalsMichael Swit
Presentation at the Center for Professional Advancement (CFPA) Course on Generic Drug Approval, August 2013. New Brunswick, NJ., with a focus on how the 1984 Hatch-Waxman Act came to be enacted.
The document discusses the importance of regulatory affairs in the pharmaceutical industry. It describes how regulatory affairs acts as the bridge between pharmaceutical companies and government regulatory agencies by ensuring drug products meet all necessary quality, safety, and efficacy standards before and after approval. Key responsibilities of regulatory affairs include managing clinical trials and submissions, maintaining compliance with all regulations, and advising companies on regulatory requirements and strategies. Strict regulations are necessary to protect public health after past drug failures and disasters.
ANDAs, OTCs, Orphans and Cosmetics – Key IssuesMichael Swit
June 24, 2015 lecture to RAC Test review course sponsored by San Diego Regulatory Affairs Network (SDRAN). Focus:
♦ ANDAs and generic drug regulation
♦ OTC drug regulation
♦ Orphan drug regulation
♦ Cosmetic Regulation
The FDA has a long history dating back to the early 19th century when organizations were established to set standards for drugs and food. Over time, in response to issues like unsafe drugs killing many Americans, the FDA was created through laws like the 1906 Pure Food and Drug Act. The FDA now regulates food, drugs, medical devices, cosmetics and more to protect public health. It ensures products are safe and properly labeled through inspections and enforcement of cGMP regulations. The FDA works with other domestic and international groups to harmonize standards globally.
ANDAs, OTCs, Orphans and Cosmetics – Key IssuesMichael Swit
August 7, 2013 lecture to RAC Test review course sponsored by San Diego Regulatory Affairs Network (SDRAN). Focused on:
♦ ANDAs and generic drug regulation
♦ OTC drug regulation
♦ Orphan drug regulation
♦ cosmetic regulation
This document discusses balancing pharmaceutical innovation and public health. It notes that while the current patent system incentivizes drug development, it can compromise access and public health goals in some cases. Problems include inappropriate patents, patents not rewarding true discoverers, and manipulation of regulations. Some areas like antibiotics face misaligned incentives as short courses are unlikely to be blockbusters. Proposed reforms address patent and regulatory abuse while ensuring important new drugs are created.
The document provides information about the US Food and Drug Administration (FDA):
- The FDA is a regulatory agency within the US Department of Health that is responsible for protecting public health by ensuring the safety of foods, drugs, medical devices, and other products.
- The FDA regulates a wide range of products including biologics, cosmetics, drugs, foods, medical devices, radiation-emitting electronics, veterinary products and tobacco.
- The agency is organized into centers that focus on specific regulatory areas like drugs, biologics, foods and medical devices. Major regulations are codified in the Code of Federal Regulations Title 21.
Successfully Responding to FDA Inspections (483s) & Warning LettersMichael Swit
This document summarizes a presentation on responding to FDA inspections and warning letters. It discusses Commissioner Hamburg's 2009 speech that revived FDA's compliance culture and enforcement efforts. It outlines FDA's expectations for timely responses to Form 483 observations and warning letters. It provides tips for how companies can prepare for and handle inspections, including designating personnel roles and training employees. It also offers guidance on writing effective responses to Form 483s and warning letters that address each violation, present corrective actions, and minimize future regulatory risks.
The document discusses the process of drug development and approval, including the role of generic drugs. It covers the following key points:
1. There are 5 stages of drug development from discovery to post-marketing trials. Generic drugs can enter after patents and exclusivity expire through an abbreviated approval process requiring only proof of bioequivalence rather than full clinical trials.
2. The Hatch-Waxman Act of 1984 aimed to balance incentives for innovation with increased generic competition. It established provisions for patent term extensions and periods of marketing exclusivity for innovators as well as an abbreviated approval pathway for generics.
3. Generics must file an ANDA demonstrating bioequivalence to the reference drug and can
This document provides definitions and explanations of key concepts and terms related to regulatory affairs in the pharmaceutical industry. It defines regulatory affairs as the interface between the pharmaceutical industry and drug regulatory authorities, and describes their main roles as ensuring safety, efficacy and quality of drugs; ensuring appropriate product information; and acting as a liaison with regulatory agencies in submissions and ensuring compliance. It goes on to define various application types such as NDA, ANDA, IND, MAA, DMF and ASMF. It also covers regulatory guidelines, agencies and procedures.
The Drug Price Competition and Patent Term Restoration Act of 1984: The Basi...Michael Swit
Presentation at the Center for Professional Advancement (CFPA) Course on Generic Drug Approval, September 2009 at Teva Parenterals, with a focus on the key basic provisions of the 1984 Hatch-Waxman Act
This generally deals with ANDA litigation in United states with Paragraph iv litigation generally. It also emphasizes on Cost involved in ANDA litigation with different methods for reducing the cost.and how many million or billion at stake when Generic and Branded drugs. It also covers the litigation part of District New Jersey that how and in what manner litigation with respect to Hatch-waxman act an is done along with the timelines and CAFC timelines.
The document summarizes the history and development of drug regulation laws in the United States from the early 1900s to present day. Key acts and amendments established safety testing requirements for drugs, created the FDA, and defined the modern drug approval process including preclinical research and multi-phase clinical trials. The modern system aims to balance drug accessibility while ensuring safety and efficacy through a rigorous review and oversight process from development through post-marketing.
GMP Review -- Legal Letter from America Column -- How Data Integrity Issues S...Michael Swit
Article appearing in the October 2018 issue of GMP Review by Michael A. Swit explores how data integrity issues sunk a $4.3 billion acquisition of Akorn by Fresenius. Article stresses lessons not just for quality professionals, but also their top management.
FDA Regulation of Promotion & Advertising -- Part 8: Handling Promotional Com...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,November 2, 2018, Boston.
FDA Regulation of Promotion & Advertising -- Part 7: FTC RegulationMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,
FDA Regulation of Promotion & Advertising -- Part 6: First Amendment, Off-Lab...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 2, 2018, Boston.
FDA Regulation of Promotion & Advertising -- Part 5: Social Media & InternetMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston
FDA Regulation of Promotion & Advertising -- Part 4: FDA Enforcement – Action...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston.
FDA Regulation of Promotion & Advertising -- Part 3: Disseminating Scientific...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston
FDA Regulation of Promotion & Advertising --Part 2: Direct-to-Consumer AdsMichael Swit
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Generic Drugs and Biosimilars
1. Solving FDA Legal Challenges for the Life of a Life Sciences Company -1- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
Generic Drugs and Biosimilars
SDRAN RAC Review Course
June 14, 2018
Michael A. Swit, Esq.
Managing Principal
2. Solving FDA Legal Challenges for the Life of a Life Sciences Company -2- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
Standard Disclaimers
• Views expressed here are solely mine and do not
reflect those of my firm or any of its clients.
• This presentation supports an oral briefing and
should not be relied upon solely on its own to
support any conclusion of law or fact.
• These slides are intended to provide general
educational information and are not intended to
convey legal advice.
3. Solving FDA Legal Challenges for the Life of a Life Sciences Company -3- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
The Basics
➢ In the beginning, there were no legal generics…
➢ The 1906 Act and Drug Law
– Misbranding
– Adulteration
– No new drug application provisions
➢ The 1938 Act
– Added new drug provisions
4. Solving FDA Legal Challenges for the Life of a Life Sciences Company -4- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
Basics …
➢ 1938 Act …
– Did not directly address generics
➢ Marketplace reality
– “Not new drug” rulings – early ’40’s
– “Me too’s” entered market
➢ 1962 Act
– Efficacy added
– D.E.S.I created
5. Solving FDA Legal Challenges for the Life of a Life Sciences Company -5- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
D.E.S.I.
➢ Laid foundation for first approved generics
➢ By 1970, the ANDA created
➢ Problem
– Only applied to pre-’62 drug found effective under DESI
➢ Solution??? -- the “Paper NDA” -- 1978
6. Solving FDA Legal Challenges for the Life of a Life Sciences Company -6- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
1984 …
➢ Not just a cool novel
➢ Birth of the modern generic industry
➢ Compromise – smoke-filled room legislation
➢ “Drug Price Competition and Patent Term
Restoration Act of 1984”
➢ Enacted – September 24, 1984
7. Solving FDA Legal Challenges for the Life of a Life Sciences Company -7- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
Waxman-Hatch Basics
➢ Any person could file an ANDA for a drug approved
under § 505(b) of the Federal Food, Drug, and Cosmetic
Act – “the listed drug”
➢ Requirements
– Same active ingredient
– Same conditions of use (labeling)
– Same dosage form
– Same strength
– Same route of admin.
– Bioequivalent
– Patent Certification
8. Solving FDA Legal Challenges for the Life of a Life Sciences Company -8- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
Basics …
➢ ANDA Suitability Petitions – for some changes
➢ Listing of patents and approved drugs – the “Orange
Book”
➢ Patent term restoration –
– On new chemical entities – maximum is five years
– Formula = 50% development time + 100% review time (less any
non-diligent time) up to 5 years with a maximum length after
extension of 14 years
9. Solving FDA Legal Challenges for the Life of a Life Sciences Company -9- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
Basics …
➢ Exclusivity
– 5-year – NCE
– 3-year – new uses for previously approved drugs
• New clinical investigations
• Conducted or sponsored
• By applicant
• Essential to approval
– 180-day for ANDAs (more later)
• patent challenge-related
• competitive generic therapies
10. Solving FDA Legal Challenges for the Life of a Life Sciences Company -10- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
Basics …
➢ Patent listings – by innovator
– 30 days of new approval
– 30 days of issuance if drug already approved
➢ Patent Certifications – by ANDA applicant
– I – no information filed
– II – filed patent has expired
– III – will await patent expire
– IV – won’t infringe or patent invalid – requires notice to patent
holder with detailed statement of law and fact for why patent
should not block ANDA
11. Solving FDA Legal Challenges for the Life of a Life Sciences Company -11- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
Safe Harbor for ANDA R&D on Patent-
Protected RLD
➢ History: Court held “patent infringement” includes
precommercial testing of product
(flurazepam/Dalmane®)
(Roche v. Bolar, Federal Circuit, 1984)
➢ Waxman Hatch Act -- Overturned Roche v. Bolar –
– may make, use or sell a patented drug during the patent life if
solely for uses reasonably related to the development and
submission of information under a federal law which regulates
the manufacture, use or sale of drugs
12. Solving FDA Legal Challenges for the Life of a Life Sciences Company -12- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
Safe Harbor for ANDA R&D on Patent-
Protected RLD
➢ Safe Harbor -- applies to innovator and generic firms
(Bristol-Myers Squibb v. Rhone-Poulenc Rorer, S.D.N.Y. 2001, aff’d, 3rd Circuit,
2003)
➢ “Reasonably Related” -- means having a decent prospect that the
“use” would generate the kind of information relevant to FDA approval
requirements
– Construed:
• Intermedics v. Ventritex, N.D.Ca. 1991, aff’d, Federal Circuit, 1993 – clinical
trials on intermediates, yes
• Medtronic v. Lohr, U.S. Supreme Court, 1996 – applies to medical devices
• Integra Life Sciences v. Merck, U.S. Supreme Court, 2005 – preclinical research
to identify future candidate, yes
13. Solving FDA Legal Challenges for the Life of a Life Sciences Company -13- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
The Concept of the Listed Drug
➢ Required for ANDA Approval
➢ Generic must be the same as the RLD
➢ Before 1984 – Federal Register Notices Declared
DESI Drugs to be “Effective”
➢ Now Appear in FDA’s Orange Book, updated
monthly
14. Solving FDA Legal Challenges for the Life of a Life Sciences Company -14- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
The Orange Book
15. Solving FDA Legal Challenges for the Life of a Life Sciences Company -15- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
Electronic Orange Book
Source: http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm
16. Solving FDA Legal Challenges for the Life of a Life Sciences Company -16- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
Electronic Orange Book
➢ Search in 4 Categoris
– Proprietary Name, Active Ingredient, or Application #
– Applicant
– Dosage Form
– Route of Administration
➢ Discontinued
– Request FDA Determination that RLD Was Not Withdrawn
from the Market for Reasons of Safety or Efficacy
• FDA Answers: Approved Discontinued Drug Products Safety and
Effectiveness Determinations
17. Solving FDA Legal Challenges for the Life of a Life Sciences Company -17- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
➢ Orange Book Annual Edition (PDF - 8.6MB)
38th Edition - The publication identifies drug products approved on the basis of
safety and effectiveness by the Food and Drug Administration under the Federal
Food, Drug, and Cosmetic Act.
➢ Orange Book Current Cumulative Supplement 2018 (PDF - 850KB)
The monthly Cumulative Supplement publication provides information on newly
approved drugs, changes and revisions to current data including therapeutic
equivalence evaluations, and updated patent and exclusivity data.
➢ Appendix A: Product Name Index (PDF - 168KB)
Prescription and OTC drug product lists. An index of drug products by
established or trade name. Updated quarterly.
➢ Appendix B: Product Name Sorted by Applicant (PDF - 410KB)
Product Name Index listed by Applicant (prescription and OTC product lists).
Cross-references applicants to drug products. Updated quarterly.
➢ Appendix C: Uniform Terms (PDF - 25KB)
Uniform terms used to designate dosage forms and routes of administration;
abbreviations used to designate strengths.
Orange Book – Other Publications
17
18. Solving FDA Legal Challenges for the Life of a Life Sciences Company -18- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
➢ Additions/Deletions for Prescription and OTC Drug Product Lists
Additions and deletions to the Prescription and OTC Drug Product Lists for a specific
month
➢ Orange Book Data Files (compressed) (ZIP - 701KB)
Download the Orange Book Data files (updated monthly). For more information, including
the descriptions of data fields in the Orange Book Search, see Orange Book Data Files.
➢ Reference Listed Drugs by ANDA Reference Standard List (PDF - 91KB)
List of drug products approved under an Abbreviated New Drug Application (ANDA) that
FDA has selected as reference standards and the associated reference listed drugs
(RLDs). More
➢ Orange Book Patent Listing Dispute List
➢ Frequently Asked Questions on The Orange Book
➢ Frequently Asked Questions on Patents and Exclusivity Drug patents and exclusivity: FDA
answers the most frequently asked questions (FAQs).
➢ Orange Book Preface -- provides info on how the book came to be, relevant terms and
codes, user responsibilities and more.
➢ FDA introduces reference standard data updates to the Orange Book An outline of data
updates to "Approved Drug Products with Therapeutic Equivalence Evaluations," or the
Orange Book, completed January 25, 2017.
Orange Book – Additional Resources
18
19. Solving FDA Legal Challenges for the Life of a Life Sciences Company -19- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
Another Waxman-Hatch Creation –
The 505(b)(2) NDA
➢ Not a completely new product (usually)
➢ Not a generic
➢ A product with some differences from a previously
approved product
➢ Approval requires (usually) clinical data, but the
studies may have been conducted by others.
20. Solving FDA Legal Challenges for the Life of a Life Sciences Company -20- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
How is 505(b)(2) Different?
➢ The applicant and FDA may rely on prior FDA
safety and efficacy determinations, based on
studies conducted by someone else even though
the applicant does not have a right of reference to
the data. 21 U.S.C. § 355(b)(2)
➢ Safety and efficacy can also be supported by
published reports
21. Solving FDA Legal Challenges for the Life of a Life Sciences Company -21- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
Types of 505(b)(2) NDAs
➢ New Chemical Entity (rarely)
➢ Changes to a Previously Approved Drug
– New dosage form, dosing regimen, strength, or route of
administration
– New indication
– New active ingredient
– New inactive ingredient that requires studies beyond limited
confirmatory studies
– Rx → OTC switch (Claritin)
➢ Duplicates of approved drugs that cannot be
approved under an ANDA
22. Solving FDA Legal Challenges for the Life of a Life Sciences Company -22- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
Exclusivity
Under Waxman-Hatch
23. Solving FDA Legal Challenges for the Life of a Life Sciences Company -23- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
Statutory Exclusivities Under
Waxman-Hatch
➢ New Chemical Entity (NCE) Exclusivity
– Prohibits the filing of an ANDA (or 505(b)(2) NDA) for a
product that contains the NCE for 5 years after approval of
the first NDA.
• (4 years if ANDA includes a Paragraph IV challenge to listed patent)
– NCE: "a drug that contains no active moiety that has been
approved by FDA in any other [NDA]."
24. Solving FDA Legal Challenges for the Life of a Life Sciences Company -24- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
Statutory Exclusivities …
➢ 3-Year Exclusivity
– Available for NDAs which contain:
• Reports of "new" "clinical trials"
• That were "essential to approval" of the NDA
• Conducted or sponsored by the applicant
– FDA may not approve (but can submit) an ANDA or
505(b)(2) NDA for 3 years after approval
– Applies for new indications, Rx → OTC switch, new dosing
regimen, and some other labeling changes.
25. Solving FDA Legal Challenges for the Life of a Life Sciences Company -25- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
Statutory Exclusivities -- Other
➢ Orphan Drug Exclusivity
– 7 year exclusivity
– Drugs for rare conditions (<200,000 people in U.S.)
➢ Pediatric Exclusivity
– 6-month extension of existing patent or Waxman-Hatch
exclusivity
➢ 180-day generic (ANDA) exclusivity
– patent challenges
– competitive generic therapies
26. Solving FDA Legal Challenges for the Life of a Life Sciences Company -26- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
“180-Day” or “ANDA” Exclusivity
➢ Basics:
– First person to file an ANDA with a Paragraph IV certification
gets 180 days during which no other ANDA can be approved for
that drug
– Must either (a) not be sued by brand co. in 45-day period or (b)
prevail in litigation (or get favorable settlement)
– 180 days starts from earlier of:
• Date of first commercial marketing (changed in 2003; used to peg to a court
decision as well)
27. Solving FDA Legal Challenges for the Life of a Life Sciences Company -27- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
“180-Day” or “ANDA” Exclusivity
➢ Advantage – ideally, incentive to pick apart patents, thus
getting generics to market earlier
➢ Problems:
– Complicated by FDA interpretations later ruled wrong by courts
– e.g., must be sued to get it
– Subject to abuse -- if first to file (and, thus, eligible for ANDA
Exclusivity) stays off market, but there is no court decision (e.g.,
via settlement with brand name) –means no other generic can
get approved as 180-day period is never triggered – addressed by
2003 legislation
28. Solving FDA Legal Challenges for the Life of a Life Sciences Company -28- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
➢ Enacted under FDARA (2017) -- adds §506H of
FFDCA
➢ Designation – if there is no more than one RLD or one
generic under that RLD
– request before or upon submission of an ANDA
➢ 180-day exclusivity – for first “CGT” to get approval for
an RLD for which there are no unexpired exclusivities or
patents
“Competitive Generic Therapies”
28
29. Solving FDA Legal Challenges for the Life of a Life Sciences Company -29- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
29
Labeling Carve-Outs (“Little viii” Statement) –
An Exclusivity-generated Situation
➢ Authorized by FFDCA, Sec. 505(j)(2)(A)(v)
– Generic drug must have same labeling as RLD, except for changes
required because of different manufacturers
➢ Preferred by FDA, 21 CFR 314.94(a)(7), (8)
– Generic labeling may omit an indication or other labeled aspect that is
protected by patent or exclusivity
➢ Upheld by Courts
– “The statute expresses the legislature's concern that the new generic be safe and effective
for each indication that will appear on its label; whether the label for the new generic lists
every indication approved for the use of the pioneer is a matter of indifference.“ Bristol
Myers Squibb Co. v. Shalala, 91 F.3d 1493, 1500 (D.C. Cir. 1996).
– Sigma-Tau Pharmaceuticals, Inc. v. Schwetz, 288 F .3d 141 (4th Cir. 2002) (orphan drug
exclusivity).
30. Solving FDA Legal Challenges for the Life of a Life Sciences Company -30- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
30
Labeling Carve-Outs …
➢ Differences must not render the proposed product less safe or
effective than the RLD for all remaining, non-protected
conditions of use. 21 CFR 314.127(a)(7)
➢ Rapamune (sirolimus) – Carve-out Denied
– 3-yr Excl. for cyclosporine withdrawal regimen, extensive info from
clinical study throughout labeling, protected labeling info essential to
safe and effective use of the drug
– FDA: Labeling contains extensive, critical prescribing info that
doctors should receive to determine treatment for any indication.
Sept. 20, 2004, Docket FDA-2003-P-00002.
➢ Oxandrin (oxandrolone) – Carve-out Upheld
– 3-yr Excl. for geriatric use, clinical study info in labeling
– FDA: all S&E issues within general adult population are adequately
addressed in labeling without geriatric-specific info. Dec. 1, 2006,
Docket FDA-2005-P-0368.
31. Solving FDA Legal Challenges for the Life of a Life Sciences Company -31- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
Waxman-Hatch & Patents
31
32. Solving FDA Legal Challenges for the Life of a Life Sciences Company -32- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
32
Generic Firm’s Duties -- Triggered By Patents
➢ Be Aware Of Patent Status
– Infringement = triple damages
– Search Orange Book and PTO
➢ Patent Certification, 21 CFR 314.94(a)(12)
➢ Amend Patent Cert. Until ANDA Approval
33. Solving FDA Legal Challenges for the Life of a Life Sciences Company -33- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
33
ANDA Patent Certifications
No -- Orange Book Patent
• Paragraph 1 – Patent
information not submitted to
FDA
• Paragraph 2 – Patent has
expired
• No Relevant Patents
Statement – No Patents exist
Yes -- Orange Book Patent
• Paragraph 3 – Will not market
until patent expires
• Paragraph 4 – Challenging the
patent as invalid, unenforceable
or not infringed
• Little viii Statement – Patent
not infringed because not seeking
approval for that use; use will not
be on label (Method of Use
Carve-Out)
34. Solving FDA Legal Challenges for the Life of a Life Sciences Company -34- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
34
Para. IV Patent Certification
➢ Submit Completed ANDA
➢ Receive FDA Letter That ANDA Has Been
Received
➢ Send Notice To NDA Sponsor/Patent Holder
➢ Notice Must Contain:
- ANDA No. - Drug Info.
- Patent No. - Expiry Date
- Scientific Rationale why no infringement/invalid
- Offer to Provide Access to ANDA, if no infringement
- Legal Brief supporting position
35. Solving FDA Legal Challenges for the Life of a Life Sciences Company -35- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
35
Para. IV Patent Certification
➢ Amend ANDA to Inform FDA of Notice
➢ Get Receipt of Delivery Confirmation and Submit
to FDA, 21 CFR 314.95
➢ NDA Sponsor Has 45 Days to Sue, Starting Day
After Notice is Received
➢ Suit Triggers 30-month Stay Against ANDA
Approval
➢ Amend ANDA “Immediately” to Inform FDA of
Suit
36. Solving FDA Legal Challenges for the Life of a Life Sciences Company -36- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
36
30-Month Stay Rules
➢ FDA Is Prohibited From Approving The
ANDA For A Period Of:
– Either 30 Months Counted From Day of NDA
Holder’s Receipt of Notice
– Or Until the Day of a Favorable Court Decision
– Whichever Occurs First
37. Solving FDA Legal Challenges for the Life of a Life Sciences Company -37- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
37
30-Month Stay Rules
➢ Definition of “Favorable Court Decision” –
either of these:
– District Court Judgment or Settlement Order
– Appellate Court Judgment or Settlement Order
38. Solving FDA Legal Challenges for the Life of a Life Sciences Company -38- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
38
30-Month Stay Rules
➢ FDA Amendments Act of 2007
➢ 30-Month Stay Can Be Extended -- if FDA Decides
that a Pending Citizen Petition Must Cause a Necessary
Delay in the ANDA Approval
➢ Extension Equals -- Length of Time from FDA’s
Receipt of Petition to FDA’s Grant/Denial of Petition
39. Solving FDA Legal Challenges for the Life of a Life Sciences Company -39- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
39
Later-Listed Patents
➢ Definition: Patents Listed With FDA After An
ANDA Is Filed With FDA
– Submit Patent Cert. & Notice, But 45-Day Clock & 30-
Month Stay Are NOT Triggered
40. Solving FDA Legal Challenges for the Life of a Life Sciences Company -40- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
Other Issues on Patents & Exclusivity
➢ Key provisions:
– Declaratory judgment action by ANDA applicant – have
to wait until 45-day period over and not sued
– “Delisting” Counterclaim to Infringement Action --
[505(j)(5)(C)(ii)]
• Not an independent cause of action
– 180-day Exclusivity
• Can be forfeited
• Pegged solely to commercial marketing – thus, implicitly allow
“authorized generics” – by any “first applicant”
41. Solving FDA Legal Challenges for the Life of a Life Sciences Company -41- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
Anti-Generic Strategies
➢ Patent listing, litigation
– Development of follow-on/ancillary patents
• Strategy now impacted by Title XI – Access to Affordable Pharmaceuticals
Act – part of 2003 Medicare Reform
➢ Amendments seeking 3-year exclusivity
– New indication for original product (limited utility)
– Changed dosage form
– New dosing regimen
– New strength(s)
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What’s in a Name?
➢ Drug Price Competition and Patent Term
Restoration Act of 1984
➢ “Waxman-Hatch Act” – universally called that until
1994
➢ 1994 – Republicans take control of Congress – “Hatch-
Waxman Act”
➢ 2006 – Democrats take control of Congress
➢ So what do you call it now? – well, the first part of the
statutory name – Drug Price Competition – relates to
Waxman’s role; and the second part – Patent Term
Restoration – refers to Hatch’s role in pushing the 1984
compromise.
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Biosimilars
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The Future is Here – “Biosimilars!”
➢ Previously – no legal mechanism can be used to
support approval of a “generic” biologic
➢ Why?
– Legally, biologics licensed under Public Health Service Act, not
Waxman-Hatch
– Difficulty in characterization
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“Generic” “Biologics”
"One cannot completely characterize the biological product
and that in itself is an issue, and quite frankly with
biological products you really don’t have a homogeneous
product, you have a defined range of biological
components for which you find consistency in a particular
clinical outcome. The challenges of analytical technology
are still very great for characterizing biologics."
-- Katherine Zoon, CBER
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Biosimilars Under 505(b)(2)
➢ For Biologics originally approved under an NDA,
FDA will accept a 505(b)(2) for a generic or
biosimilar version
– Examples include naturally-derived active ingredients (from
animal or botanical sources) or those derived from recombinant
technology (e.g., insulin, HGH)
– None have a TE rating
– Lovenox® – (LMWH) -- approved in July 2010 and arguably a
biologic – approved as an ANDA
➢ For BLA-approved products, no “generic” or
abbreviated approval pathway existed
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The 2010 Law – the BPCIA
➢ Creates an “abbreviated” pathway for Biosimilars
➢ “Biosimilar” defined
– that the biological product is highly similar to the reference product
notwithstanding minor differences in clinically inactive
components; and
– there are no clinically meaningful differences between the
biological product and the reference product in terms of the
safety, purity, and potency of the product.
– Contrast to small molecule – ANDA – drug must be same
– Reason – so difficult to characterize and process
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Basics
➢ To show biosimilarity, application must contain:
– analytical studies that demonstrate that the biological product is
highly similar to the reference product notwithstanding minor
differences in clinically inactive components;
– animal studies (including the assessment of toxicity); and
– a clinical study or studies (including the assessment of
immunogenicity and pharmacokinetics or pharmacodynamics) that
are sufficient to demonstrate safety, purity, and potency in 1 or
more appropriate conditions of use for which the reference product
is licensed and intended to be used and for which licensure is
sought for the biological product.
➢ FDA can waive any of those
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Basics …
➢ The biological product and reference product must
utilize the same mechanism or mechanisms of action for the
condition or conditions of use prescribed,
recommended, or suggested in the proposed labeling,
but only to the extent the mechanism or mechanisms of
action are known for the reference product;
➢ The condition or conditions of use prescribed,
recommended, or suggested in the labeling proposed for
the biological product have been previously approved for
the reference product;
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Basics …
➢ The route of administration, the dosage form, and
the strength of the biological product are the same
as those of the reference product
➢ The facility in which the biological product is
manufactured, processed, packed, or held meets
standards designed to assure that the biological
product continues to be safe, pure, and potent.
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Interchangeability
➢ Not required, but allowed
– The term ‘interchangeable’ or ‘interchangeability,’ in reference to a
biological product -- means that the biological product may be
substituted for the reference product without the intervention of the
health care provider who prescribed the reference product.
➢ However, to prove interchangeability, FDA has said:
– To establish that two protein products would be therapeutically
equivalent (interchangeable), a sponsor of the follow-on protein
product would need to demonstrate, among other things that repeated
switches from the follow-on protein product to the referenced product,
and vice versa, would have no negative effect on the safety and
effectiveness of the products.
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Exclusivity
➢ Innovator –12 years from date of first licensure
– Retroactive – captures BLAs approved before statute’s
enactment in March 2010
– Can also qualify for pediatric exclusivity extension
– First four years – abbreviated app. can NOT be submitted
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Exclusivity …
➢ First Interchangeable Biosimilar
– Applicant gets period of time where no other interchangeable for
same Reference Product (i.e., innovator) can be approved
– Length varies depending on a variety of factors; earliest of:
• One year of first commercial marketing
• 18 months of favorable final court decision in patent litigation
• 42 months of approval if First Interchangeable tied up in patent litigation
• 18 months of First Interchangeable if no law suit
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First Two 351(k) Approvals
➢ Sandoz – July 24, 2014 – announced FDA had
accepted for filing its Biosimilar application for a
version of Amgen’s Neupogen® (filgrastim)
– Approved March 2015 as “Zarxio”
➢ Celltrion – August 11, 2014 – announced it had
“completed the filing process” at FDA for its
Biosimilar application for a version of Janssen’s
Remicade®
– using its own trade name -- was Remsima®, but changed to
Inflectra
– first MAB biosimilar
– Approved on April 5, 2016
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➢ State laws – patchwork of various requirements relating
to prescribing and/or substitution
➢ Pricing – difference from innovators are not great
➢ NOT a generic – is a “branded” play due to expense of
devleopment
➢ Reimbursement – runs gamut, but many plans require
patient to use brand first
➢ Naming – FDA will apply a unique suffix to the
biosimilar established (generic) name such as “filgrastim-
vkzt” for Teva/Cephalon’s Granix®
Many Issues Remain on Biosimilars
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Questions?
➢ Call, e-mail or write:
Michael A. Swit, Esq.
LAW OFFICES OF MICHAEL A. SWIT
San Diego, California 92130
m: 760-815-4762
e: mswit@fdacounsel.com
web: www.fdacounsel.com
➢ Follow me on:
– LinkedIn: http://www.linkedin.com/in/michaelswit
– Twitter: https://twitter.com/FDACounsel
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About Your Speaker
Michael A. Swit, Esq., has been addressing critical FDA legal and regulatory issues for over 30
years. Before returning to his private law practice in late 2017, he served for 3 years as the chief
regulatory counsel at Illumina, Inc., the world’s leading developer of gene sequencing technologies.
Prior to that, Swit was a special counsel in the FDA Law Practice at the global law firm of
Duane Morris LLP, in its San Diego office. Before joining Duane Morris in March 2012, Swit served
for seven years as a vice president at The Weinberg Group Inc., a preeminent scientific and
regulatory consulting firm in the Life Sciences.
His expertise includes product development, compliance and enforcement, recalls and crisis
management, submissions and related traditional FDA regulatory activities, labeling and advertising,
and clinical research efforts for all types of life sciences companies, with a particular emphasis on
drugs, biologics, therapeutic biotech products, medical devices, and IVDs.
His FDA legal and regulatory work also has included tenures in private practice with McKenna &
Cuneo and Heller Ehrman, and as vice president, general counsel and secretary of Par
Pharmaceutical, a top public generic and specialty drug firm, where he helped spearhead the
company’s emergence from the Generic Drug Scandal. He also was, from 1994 to 1998, CEO of
FDANews.com, a premier publisher of regulatory newsletters and other specialty information
products for FDA-regulated firms.
He has taught and written on many topics relating to FDA regulation and associated commercial
activities and is a past member of the Food & Drug Law Journal Editorial Board. He earned his
A.B., magna cum laude, with high honors in history, at Bowdoin College, and his law degree at
Emory University.