Drug Types: Biosimilars, generics and more. December 2017 Webinar 12122017Fight Colorectal Cancer
Specialty pharmacist Stevan Lalich of CVS Health breaks down the differences between biosimilar, biologic, generic, and brand name drugs – and why it’s important! In this comprehensive webinar, learn about the medicines in your cabinet and the process they endure before reaching you. This is a timely and unique webinar not to be missed
Presentation at the Center for Professional Advancement (CFPA) Course on Generic Drug Approval, August 2013. New Brunswick, NJ., with a focus on how biosimilars are regulated
Statement of Inger Mollerup, VP Novo Nordisk A/S for Congressional Hearings o...sstrumello
Statement of Inger Mollerup, MSc
Vice President Novo Nordisk A/S
Before the Government Oversight and Reform Committee Hearing On "Safe and Affordable Biotech Drugs - The Need for a Generic Pathway"
March 26, 2007
Drug Types: Biosimilars, generics and more. December 2017 Webinar 12122017Fight Colorectal Cancer
Specialty pharmacist Stevan Lalich of CVS Health breaks down the differences between biosimilar, biologic, generic, and brand name drugs – and why it’s important! In this comprehensive webinar, learn about the medicines in your cabinet and the process they endure before reaching you. This is a timely and unique webinar not to be missed
Presentation at the Center for Professional Advancement (CFPA) Course on Generic Drug Approval, August 2013. New Brunswick, NJ., with a focus on how biosimilars are regulated
Statement of Inger Mollerup, VP Novo Nordisk A/S for Congressional Hearings o...sstrumello
Statement of Inger Mollerup, MSc
Vice President Novo Nordisk A/S
Before the Government Oversight and Reform Committee Hearing On "Safe and Affordable Biotech Drugs - The Need for a Generic Pathway"
March 26, 2007
Biosimilar is the term coined for protein drugs that are similar, but not identical to, an existing product. Copies of biopharmaceuticals (proteins) that can be made after the patent on the original product has expired Example: Epoetin, G-CSF, insulin, somatropin
An introductory presentation (ppt) on biosimilars and guidelines related to their approval along with the challenges faced by biosimilar industries in India.
Definition of biopharmaceuticals and biosimilars, Steps involved in manufacturing biopharmaceuticals, Points of differences between Biosimilars and Chemical Generics, Related issues with biosimilars
Biosimilars are biologic medical products that are almost identical copies of the original product that is manufactured by a different company. Biosimilars are officially approved versions of original "innovator" products and can be manufactured when the original product's patent expires.
Biosimilars, Orphans, Advanced Therapy Medicines: Current regulatory issues (...Ioanna Michalopoulou
Get a quick, up to date overview of the Biotechnology industry and particularly "Red" Biotechnology and gain an understanding of the legal challenges the industry faces right now. Case studies, entrepreneurial examples and referrals to the current regulatory issues act as a starting point to delve deeper into that booming industry.
Biosimilar is the term coined for protein drugs that are similar, but not identical to, an existing product. Copies of biopharmaceuticals (proteins) that can be made after the patent on the original product has expired Example: Epoetin, G-CSF, insulin, somatropin
An introductory presentation (ppt) on biosimilars and guidelines related to their approval along with the challenges faced by biosimilar industries in India.
Definition of biopharmaceuticals and biosimilars, Steps involved in manufacturing biopharmaceuticals, Points of differences between Biosimilars and Chemical Generics, Related issues with biosimilars
Biosimilars are biologic medical products that are almost identical copies of the original product that is manufactured by a different company. Biosimilars are officially approved versions of original "innovator" products and can be manufactured when the original product's patent expires.
Biosimilars, Orphans, Advanced Therapy Medicines: Current regulatory issues (...Ioanna Michalopoulou
Get a quick, up to date overview of the Biotechnology industry and particularly "Red" Biotechnology and gain an understanding of the legal challenges the industry faces right now. Case studies, entrepreneurial examples and referrals to the current regulatory issues act as a starting point to delve deeper into that booming industry.
In the pharmaceutical industry, patents are the preeminent incentive for innovation in developing new drugs. But patents aren’t the whole story; regulatory agencies also offer different forms of exclusivity—enforced by the agencies themselves—to encourage different forms of innovation in the industry. This panel discussed actual and potential roles for those rewards in the context of developing new drugs, new uses for old drugs, and new ways to make drugs, in both the United States and the European Union.
The biosimilars frontier is still a fairly new market, but its regulatory beginnings can be traced back to the early 2000s, with Europe, Asia and Australia among the early adopters. See the attached document for a look at the global progress of biosimilars.
Get the latest on Biosimilars at https://www.smallworldsocial.com/biolink/
Curated resources updated daily.
On March 14, 2013, Knobbe Martens Partner Carol Pitzel Cruz presented at the 24th C5 Forum on Biotech Patenting 2013. The presentation was titled "The Red Flags Every Patent Attorney Needs to Know to Successfully Navigate the Regulatory Landscape for Biosimilars" and Pitzel Cruz covered the U.S. law.
Her presentation analyzed the key features of the new Food and Drug Administration guidelines for American biosimilar approval under the Biologics Price Competition and Innovation Act.
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
Monoclonal Antibodies Dawn Of A New EraWouter Pors
Seminar on IP and regulatory aspects, Brussels, 7 June 2012, speakers Michael Alt, Trevor Cook, Liz Fuller, Marc Martens (Bird & Bird) and Frank Landolt (Ablynx)
In view of the U.S. approval process for biosimilars, companies are gearing up to either produce their own biosimilar products, or to defend against their entry onto the market. While the Biologics Price Competition and Innovation Act (BPCIA) spells out many of the requirements, the pathway for approval is complicated. Our panel of experts discuss the features of the BPCIA and how it operates for both approved biologics as well as biosimilar entrants. They also make some predictions on its impact for life science companies.
The webinar is 60 minutes, complete with Q&A.
This presentation explains concepts of Patents and Market Exclusivity. This presentation is compiled from publicly available material on the world wide web.
When do drug patents expire and when can generic drugs launch?thinkBiotech
From DrugPatentWatch.com - When do drug patents expire, and when can generic drugs launch? An overview of patents, non-patent regulatory exclusivities, and specific US and EU factors influencing generic drug launch.
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
“Principles of a Science-Based Regulatory Pathway for Biosimilar Products”
Provides an overview of the guiding principles for a science-based regulatory pathway for biosimilar products
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
Presentation about Biosimilars on Save Your Skin Foundation webinar, January 19, 2018. This is presentation #1 of 3 in the webinar: 1. Health Canada 2. CADTH 3. Louise Binder, Save Your Skin Fdn.
Hope S. Rugo, MD, FASCO, prepared useful Practice Aids pertaining to biosimilars for this CME/MOC/CNE/CPE activity titled "Biosimilars as Partners in Oncology: Expert Guidance on Understanding and Incorporating Biosimilar Agents in Real-World Care." For the full presentation, monograph, complete CME/MOC/CNE/CPE information, and to apply for credit, please visit us at http://bit.ly/38DBgFb. CME/MOC/CNE/CPE credit will be available until April 27, 2021.
UNDERSTANDING GENERIC VS INNOVATOR BUSINESSKabin Maleku
This presentation includes the basic difference between generic and innovator medicines and outline about various filling pathways for US FDA and Exclusivity and few case studies
Generating a custom Ruby SDK for your web service or Rails API using Smithyg2nightmarescribd
Have you ever wanted a Ruby client API to communicate with your web service? Smithy is a protocol-agnostic language for defining services and SDKs. Smithy Ruby is an implementation of Smithy that generates a Ruby SDK using a Smithy model. In this talk, we will explore Smithy and Smithy Ruby to learn how to generate custom feature-rich SDKs that can communicate with any web service, such as a Rails JSON API.
Slack (or Teams) Automation for Bonterra Impact Management (fka Social Soluti...Jeffrey Haguewood
Sidekick Solutions uses Bonterra Impact Management (fka Social Solutions Apricot) and automation solutions to integrate data for business workflows.
We believe integration and automation are essential to user experience and the promise of efficient work through technology. Automation is the critical ingredient to realizing that full vision. We develop integration products and services for Bonterra Case Management software to support the deployment of automations for a variety of use cases.
This video focuses on the notifications, alerts, and approval requests using Slack for Bonterra Impact Management. The solutions covered in this webinar can also be deployed for Microsoft Teams.
Interested in deploying notification automations for Bonterra Impact Management? Contact us at sales@sidekicksolutionsllc.com to discuss next steps.
Encryption in Microsoft 365 - ExpertsLive Netherlands 2024Albert Hoitingh
In this session I delve into the encryption technology used in Microsoft 365 and Microsoft Purview. Including the concepts of Customer Key and Double Key Encryption.
State of ICS and IoT Cyber Threat Landscape Report 2024 previewPrayukth K V
The IoT and OT threat landscape report has been prepared by the Threat Research Team at Sectrio using data from Sectrio, cyber threat intelligence farming facilities spread across over 85 cities around the world. In addition, Sectrio also runs AI-based advanced threat and payload engagement facilities that serve as sinks to attract and engage sophisticated threat actors, and newer malware including new variants and latent threats that are at an earlier stage of development.
The latest edition of the OT/ICS and IoT security Threat Landscape Report 2024 also covers:
State of global ICS asset and network exposure
Sectoral targets and attacks as well as the cost of ransom
Global APT activity, AI usage, actor and tactic profiles, and implications
Rise in volumes of AI-powered cyberattacks
Major cyber events in 2024
Malware and malicious payload trends
Cyberattack types and targets
Vulnerability exploit attempts on CVEs
Attacks on counties – USA
Expansion of bot farms – how, where, and why
In-depth analysis of the cyber threat landscape across North America, South America, Europe, APAC, and the Middle East
Why are attacks on smart factories rising?
Cyber risk predictions
Axis of attacks – Europe
Systemic attacks in the Middle East
Download the full report from here:
https://sectrio.com/resources/ot-threat-landscape-reports/sectrio-releases-ot-ics-and-iot-security-threat-landscape-report-2024/
GraphRAG is All You need? LLM & Knowledge GraphGuy Korland
Guy Korland, CEO and Co-founder of FalkorDB, will review two articles on the integration of language models with knowledge graphs.
1. Unifying Large Language Models and Knowledge Graphs: A Roadmap.
https://arxiv.org/abs/2306.08302
2. Microsoft Research's GraphRAG paper and a review paper on various uses of knowledge graphs:
https://www.microsoft.com/en-us/research/blog/graphrag-unlocking-llm-discovery-on-narrative-private-data/
JMeter webinar - integration with InfluxDB and GrafanaRTTS
Watch this recorded webinar about real-time monitoring of application performance. See how to integrate Apache JMeter, the open-source leader in performance testing, with InfluxDB, the open-source time-series database, and Grafana, the open-source analytics and visualization application.
In this webinar, we will review the benefits of leveraging InfluxDB and Grafana when executing load tests and demonstrate how these tools are used to visualize performance metrics.
Length: 30 minutes
Session Overview
-------------------------------------------
During this webinar, we will cover the following topics while demonstrating the integrations of JMeter, InfluxDB and Grafana:
- What out-of-the-box solutions are available for real-time monitoring JMeter tests?
- What are the benefits of integrating InfluxDB and Grafana into the load testing stack?
- Which features are provided by Grafana?
- Demonstration of InfluxDB and Grafana using a practice web application
To view the webinar recording, go to:
https://www.rttsweb.com/jmeter-integration-webinar
Key Trends Shaping the Future of Infrastructure.pdfCheryl Hung
Keynote at DIGIT West Expo, Glasgow on 29 May 2024.
Cheryl Hung, ochery.com
Sr Director, Infrastructure Ecosystem, Arm.
The key trends across hardware, cloud and open-source; exploring how these areas are likely to mature and develop over the short and long-term, and then considering how organisations can position themselves to adapt and thrive.
Software Delivery At the Speed of AI: Inflectra Invests In AI-Powered QualityInflectra
In this insightful webinar, Inflectra explores how artificial intelligence (AI) is transforming software development and testing. Discover how AI-powered tools are revolutionizing every stage of the software development lifecycle (SDLC), from design and prototyping to testing, deployment, and monitoring.
Learn about:
• The Future of Testing: How AI is shifting testing towards verification, analysis, and higher-level skills, while reducing repetitive tasks.
• Test Automation: How AI-powered test case generation, optimization, and self-healing tests are making testing more efficient and effective.
• Visual Testing: Explore the emerging capabilities of AI in visual testing and how it's set to revolutionize UI verification.
• Inflectra's AI Solutions: See demonstrations of Inflectra's cutting-edge AI tools like the ChatGPT plugin and Azure Open AI platform, designed to streamline your testing process.
Whether you're a developer, tester, or QA professional, this webinar will give you valuable insights into how AI is shaping the future of software delivery.
UiPath Test Automation using UiPath Test Suite series, part 4DianaGray10
Welcome to UiPath Test Automation using UiPath Test Suite series part 4. In this session, we will cover Test Manager overview along with SAP heatmap.
The UiPath Test Manager overview with SAP heatmap webinar offers a concise yet comprehensive exploration of the role of a Test Manager within SAP environments, coupled with the utilization of heatmaps for effective testing strategies.
Participants will gain insights into the responsibilities, challenges, and best practices associated with test management in SAP projects. Additionally, the webinar delves into the significance of heatmaps as a visual aid for identifying testing priorities, areas of risk, and resource allocation within SAP landscapes. Through this session, attendees can expect to enhance their understanding of test management principles while learning practical approaches to optimize testing processes in SAP environments using heatmap visualization techniques
What will you get from this session?
1. Insights into SAP testing best practices
2. Heatmap utilization for testing
3. Optimization of testing processes
4. Demo
Topics covered:
Execution from the test manager
Orchestrator execution result
Defect reporting
SAP heatmap example with demo
Speaker:
Deepak Rai, Automation Practice Lead, Boundaryless Group and UiPath MVP
Dev Dives: Train smarter, not harder – active learning and UiPath LLMs for do...UiPathCommunity
💥 Speed, accuracy, and scaling – discover the superpowers of GenAI in action with UiPath Document Understanding and Communications Mining™:
See how to accelerate model training and optimize model performance with active learning
Learn about the latest enhancements to out-of-the-box document processing – with little to no training required
Get an exclusive demo of the new family of UiPath LLMs – GenAI models specialized for processing different types of documents and messages
This is a hands-on session specifically designed for automation developers and AI enthusiasts seeking to enhance their knowledge in leveraging the latest intelligent document processing capabilities offered by UiPath.
Speakers:
👨🏫 Andras Palfi, Senior Product Manager, UiPath
👩🏫 Lenka Dulovicova, Product Program Manager, UiPath
Accelerate your Kubernetes clusters with Varnish CachingThijs Feryn
A presentation about the usage and availability of Varnish on Kubernetes. This talk explores the capabilities of Varnish caching and shows how to use the Varnish Helm chart to deploy it to Kubernetes.
This presentation was delivered at K8SUG Singapore. See https://feryn.eu/presentations/accelerate-your-kubernetes-clusters-with-varnish-caching-k8sug-singapore-28-2024 for more details.
2. U.S. Biosimilars
• US Regulatory approach to “follow-on biologics” (FOB)
Approval Pathway
Litigation Scheme
• FDA-Upcoming Hearings (Nov.2-3, 2010)
Issues for FDA
Strategic Ramifications
• European Union’s “Biosimilars” lead
Guidance for Antibody Biosimilars-November
3. Biosimilar is not Generic
• Traditional pharmaceutical
– small organic molecule
– synthesized in the lab
– purity can be verified
• A generic drug
– has same active ingredient
– but may have a different formulation
– such as other ingredients
• affect absorption or half life
4. Biological Molecules
• Natural or synthetic products
– typically produced in cells
• Structure dependent on
– process of making
– cell type used to produce
• More complicated to purify
5. Biologics are Different
• Biological origin
• Large molecules
• Heterogeneous
• Self-replicating
• Multifunctional
• Variable
• Manufacturing
process-dependent
• Immunogenicity
• Changes clinically
relevant
6. Biologic Products
• >174 biological products approved
– most since 2000
• More products in pipeline (>500)
– pharma acquiring biotech firms
• Humanized antibodies for cancer
– Success established products
• More approvals for new indications
8. Public Expectations
• Inexpensive generic drugs that are safe and
effective-may not understand differences between
small molecule and biologic
• Physicians expect clinical trials but generally view
innovators and generic companies as trustworthy
and may be more likely to prescribe a biosimilar
• Some discount expected but not as great as small
molecule
9. Pathways for approval of
drugs
• PHSA:BLA
– Biosimilars do not fit the
generic H-W model
• FDCA:NDA/505b1 and 505b2
• Hatch-Waxman Act :ANDA/505j
10. FDCA 505(j) – Hatch
Waxman Act
Small Molecules
• Abbreviated New Drug Application (ANDA)
– Use safety/efficacy data of allowed drug
– Show proposed drug product is identical to previously
approved drug product in:
• Active ingredient
• Dosage form
• Strength
• Route of administration
• Labeling
• Quality
• Performance
characteristics
• intended use
• among other things
FFDCA 505(j)(2)(A)FFDCA 505(j)(2)(A)
11. Biologics Price Competition
and Innovation Act
• Signed into law March 30, 2010-retroactive
• Amended Public Health Service Act (BLA
standard)
• Key features
– 12 years market exclusivity before
approval of biosimilar-4 years before
first app
– Two standards of approval
• Biosimilarity
• Interchangeability(if labeled or if
exclusivity)
– Exclusivity for first approved
interchangeable product
– Complicated litigation scheme
– No orange book
12. “Biosimilar” Defined
351(k)
• “Biosimilar” or “biosimilarity” means
(A) highly similar notwithstanding
minor differences in clinically
inactive components; and
(B) No clinically meaningful
differences in terms of safety, purity,
and potency
13. Interchangeable
351(k)
“Interchangeable” or
“Interchangeability”
• Expected to produce the same
clinical result in any given patient
and the risk in terms of safety or
diminished efficacy of is not > the
risk of using the reference product
without a switch
• May be substituted without
intervention of the health care
provider
14. Content of Biosimilar
Application
• Data to show proposed product biosimilar
and interchangeable (if labeled or
exclusivity)
• Same mechanism as Ref Product
• Labeling has been previously approved for
Ref product
• Same route of administration, dosage form
and strength
• Facilities standard assure that product is
safe, pure, and potent
15. Data
• Analytic studies showing product is highly
similar
• Animal studies (including toxicity)
• Clinical Studies showing safety, purity,
and efficacy including immunogenicity
• If given more than once the risk of
switching from the ref product is not
greater than the ref product without
switching
16. Reference Product Exclusivity
• 4 years of data exclusivity-no app
accepted
• 12 years market exclusivity-no approval
• +6 extra months pediatric for both
This is irrespective of patents, which are
tied to a filing date and may expire prior
to market exclusivity expiration
17. FOB Market Exclusivity
First Approved Interchangeable
Biosimilar/Earlier of
• 1 year after 1st
commercial marketing after
approval as interchangeable;
• 18 months after final court decision(s) or
dismissal(s) on all patents in suit; or
• 42 months after approval of the 1st
FOB if 1st
applicant still has litigation pending; or
• 18 months after approval of 1st
FOB if 1st
applicant has not been sued.
18. Litigation Scheme
COMPLICATED!
• NO ORANGE BOOK!
– Exchange of patent information within 20
days of approval
– Access to confidential information
needed to determine infringement
– 60 days innovator must give notice of
patents
– Sanctions
– Tight Deadlines: Innovator must sue
within 30 days of agreement on the
patent list or only entitled to reasonable
royalty
• Patent Litigation
– No automatic stay of approval
19. Exchange of Information
• Patent lists-both sides and includes
process patents
• Claim charts-both sides
• Mandatory negotiation on which
patents are subject to suit
• Bring suit in 30 days/ no stay
• 180 days notice of intent to market
biosimilar
20. FDA Hearings
• FDA policy:
permitting appropriate
reliance on what is already
known about a drug
• Purpose:
Receive info and comments
from broad group
21. Biosimilarity
What scientific & technical factors
should the agency consider in:
1. whether the product is highly
similar; and
2. determining the appropriate
studies to assess nature &
impact of structural differences
22. Biosimilarity
3. What range of structural
differences b/t biosimilar &
ref product is consistent &
acceptable w/ “biosimilar”?
4. Under what circumstances
should FDA consider
animal or clinical studies
unnecessary for 351(k) app
23. Interchangeability
What factors should FDA
consider in:
1. determining whether
biosimilar can be expected
to produce same clin result
2. evaluating potential risk
related to alternating or
switching
24. Patient Safety and
Pharmacovigilance
FDA mush be able to distinguish between
1. Reference product;
2. Related biological product that has not
been demonstrated to be biosimilar;
3. Biosimilar product; and
4. Interchangeable product.
25. Patient Safety and
Pharmacovigilance
1. Factors in establishing its
pharmacovigilance program
2. Approaches to be undertaken by FDA,
industry, or health care to ensure
appropriate pharmacovigilance
3. Nonproprietary names
4. Safeguards when prescribing,
administering, & dispensing to prevent
unsafe substitution
5. Mechanisms to communicate findings
26. Use of Supportive
Data and Information
• What extent, if any, should
animal or clinical data
comparing biosimilar with
non-US licensed comparator
product be used to support a
demonstration of biosimilarity
to a US licensed ref product?
27. Definition of
Biological Product
BPCI Act changes the statutory authority
under which certain protein products will
be regulated
1. Developing regulatory definition of
“protein” (as distinguished from peptide or
polypeptide)
2. Developing regulatory definition of “any
chemically synthesized polypeptide
28. Guidances
• Types of guidance docs
should be a priority during
early implementation
• Factors to determine if the
existing science & experience
are sufficient to allow
approval for a product or
product class
29. Exclusivity
• What types of related entities
should be ineligible for a 12
exclusivity for a subsequent BLA?
• What type of modification to the
structure of a product that results
in a change in safety, purity, or
potency, such that a subsequent
BLA may be eligible for a 2nd
12-
year period of market exclusivity?
30. Transition Provisions
• What “product classes” may
be submitted under the FD&C
during 10 year transition
period?
• What should be considered
when determining whether a
351(k) approval can be a ref
product to a 351(a)?
31. The EU Experience
• 2005-6 EMA Guidelines produced
• 2006: EU approvals
– hGH biosimilars (Omnitrope and Valtropin)
– other evaluations started
– Data from ~200 patients, 9-12 months study
– Same INN-name as brand name product
– No EMA guidance regarding interchangeability
– Comparatively simple biotech-generated
products
32. EU Directive Biosimilars
• Biological medicinal product
– Similar to a reference biological product
– But differences
• in raw materials or manufacturing
– Pre-clinical or clinical trials must be provided
• Appropriate to the changed conditions
• type and quantity must comply with relevant criteria
• and related detailed Guidelines
• results of other tests and trials from the reference medicinal
product's dossier shall not be provided
33. EU product specific
guidelines
biosimilar rGC-SF CHMP/31329/05 June 05
biosimilar rhInsulin EMEA/CHMP/32775/05 June 06
biosimilar somatropin EMEA/CHMP/94528/05 June 06
similar rEPOs EMEA/CHMP/94526/05 July 06
Concept Paper On Similar Low
Molecular Weight Heparins - (Non)
Clinical Issues
EMEA/CHMP/BMWP/4
96286/06
Draft guideline on similar rIFNa EMEA/CHMP/BMWP/1
02046/2006
34. Basic Requirements
• Comparability in quality, safety, and efficacy to
ref. product
• Product is evaluated based on its characteristics
(eg purity), process, and formulation
need to justify any differences such as post
translation modifications or impurities
Analytical procedures:
physicochemical (primary-tertiary structure),
biological activity,
purity and impurities (process based
impurities are evaluated for clinical effect)
36. Analysis Chimeric and
Humanized Antibodies
• Many approved in 1997-1998 including
Rituxan,Remicade, Herceptin
• 6 requests for biosimilar antibody
products-Teva/Rituxan
• Improved characterization:MALDI-
TOF,NMR, Surface Plasmon
resonance, Circular dichroism-is
sensitivity sufficient
• Complex processing
• Is mechanism of action understood
• Antibodies do not substitute for natural
product so is immunogenicity a concern
• Are amino acid differences acceptable?
37. Summary
• US – leads biologic drug industry
– Need a system in place-waiting for FDA regs
• FOB/Biosimilar industry is growing
– High cost of biologics
– Incentive 75% price
– Regulatory approval hurdles
• US legislation
– More complicated than EU
– Patent litigation issues
Is the United States prepared for biosimilars/follow-on biologics? FDA and biotechnology industry says there’s no such thing as a generic biolgic. The US has suggested approaches to FOBs with 4 legislative models propoed; EPUnion taken the lead…
Bisimilar does not mean gerneric
Generic for traditional molecules – small organics synthesized in lab; easy to verify structure and purity; Typical US generics have same active ingredient - generic drug has same active but may have different formulation
Biologics are more complicated – they are natural or synthetic products, generally produced in living cells; the structure (and function) is generally dependent on the process of making, for example, the cell type used to produce ; more complicated to purify.
Biologic drugs are different from small molecule drugs
They are of biological origin; are much larger and more complex, heterogeneous and variable, self-replicating, multifunctional, structure/function is dependent on manufacturing processes; small changes can be clinically relevant; can cause immunogenicity
More than 174 products have been approved , most since 2000
Many more in the pipeline as big pharma acquires small bio firms;
Success established by humanized antibodies for cancer, with more approvals for new indications helped vault the industry and follow along products
Biosimilar products have been approved worldwide; Omnitrope (hGH), EPO, various cytokines, insulin
The US public has come to expect low cost generic drugs; Hatch Waxman Act provides for generic approval for small molecules that are the same as the approved drug. Generally thought sucessful, economists differ – problem is lack of innovator drugs (loss of time to recoup investment) No legislation as yet for FOBs – take care not to destroy this new industry – must get return on investment else no new drugs will be developed in US (compare origins of biotech industry.. US only one to patent and protect, industry started here until other countries protected innovation. Problem for new legislation, how to protect adequately, how to protect public safety when copy biologic is not the same
Hatch Waxman Act, FDCA 505j – abbreviated new drug application – uses safety and efficacy data of innovator’s drug; need to show proposed generic drug is identical to the previously approved drug in active ingredient, dosage form, strength, administration route, labeling, quality, performance, intended use, and others.
Not interchangeable means new active ingredient
Peds extension: House version, extension is in the legislation
Senate version amends subsection (a)(1) of 409I of PHSA and § 505A(p) of FDCA
FOB market exclusivity provided in the legislation – varies
HW - 180 days from first commercial marketing differs when litigation ensues
Inslee, like EP provides not FOB exclulsivity; Others require interchangable label.. None yet
Each of the new bills varies the HW model of generics; but there is no plan for an ORANGE book. Instead, parties will exchange patent information and be provided with access to confidential information as needed to determine infringement. Only HR5629 addresses the rights of third parties, e.g., Universities and other parties that may have an interest in the patents. None provides for an automatic stay of approval for patent litigation, nor provides for control of patent litigation