Diabetes blogger Scott Strumello (sstrumello.blogspot.com) investigates whether follow-on (generic) insulin formulation will soon emerge in accordance with U.S. patent law.
Publish Date: January 1, 2007
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.
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.
RyMat Inc.: A Look At Generic vs. Brand PharmaceuticalsStuart Silverman
The document discusses generics vs brand name drugs and risks associated with generics. It notes that generics must have the same active ingredients and be within 10-25% of brand name drug concentrations to be approved. However, generics may have different inactive ingredients and manufacturing processes can vary, resulting in differences between generics. The document outlines issues found at some generic drug manufacturing plants in India and China, including falsifying data, poor quality control, and hiding failed test results. It warns that not all generics are equal and some imported from these countries may pose risks.
The document provides an overview of the global pharmaceutical industry and the generic drug market. It discusses how the generic drug market is growing faster than the overall pharmaceutical industry. It also summarizes the key requirements for FDA approval of generic drugs, including bioequivalence to the branded version. Additionally, it outlines the Hatch-Waxman Act which aims to balance generic and branded drug competition in the US market.
This document summarizes a webinar about product liability risks for pharmaceutical companies in California following a recent court case, Conte v. Wyeth. The webinar discusses how the case established that innovator drug companies can be held liable for injuries caused by generic drug competitors, even if the plaintiff did not use the innovator's product. It also discusses federal preemption which can protect both innovator and generic drug companies from certain liability claims. The webinar aims to help pharmaceutical companies understand and utilize preemption as a defense in product liability lawsuits in California.
Recent FDA Developments in Digital Health & Clinical Decision Support SoftwareMichael Swit
June 7, 2018 presentation at the 4th Annual Medical Device Summit, sponsored by ComplianceOnline, in San Francisco, focusing on the impact of the 21st Century Cures Act and other developments on how FDA regulates software in the medical device arena, including mobile medical applications.
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
This document provides an overview of Merck and its recalled drug Vioxx. It discusses Merck's history, leadership, stakeholders, vision, relationship with the FDA, political contributions, use of the blockbuster drug model, direct-to-consumer advertising, Vioxx's rise to fame, emerging safety concerns, and ultimate recall from the market in 2004. The recall came after studies showed Vioxx significantly increased heart attack risks. Questions remain about whether further action should have been taken against those responsible for the deaths and damages caused to consumers by Vioxx.
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.
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.
RyMat Inc.: A Look At Generic vs. Brand PharmaceuticalsStuart Silverman
The document discusses generics vs brand name drugs and risks associated with generics. It notes that generics must have the same active ingredients and be within 10-25% of brand name drug concentrations to be approved. However, generics may have different inactive ingredients and manufacturing processes can vary, resulting in differences between generics. The document outlines issues found at some generic drug manufacturing plants in India and China, including falsifying data, poor quality control, and hiding failed test results. It warns that not all generics are equal and some imported from these countries may pose risks.
The document provides an overview of the global pharmaceutical industry and the generic drug market. It discusses how the generic drug market is growing faster than the overall pharmaceutical industry. It also summarizes the key requirements for FDA approval of generic drugs, including bioequivalence to the branded version. Additionally, it outlines the Hatch-Waxman Act which aims to balance generic and branded drug competition in the US market.
This document summarizes a webinar about product liability risks for pharmaceutical companies in California following a recent court case, Conte v. Wyeth. The webinar discusses how the case established that innovator drug companies can be held liable for injuries caused by generic drug competitors, even if the plaintiff did not use the innovator's product. It also discusses federal preemption which can protect both innovator and generic drug companies from certain liability claims. The webinar aims to help pharmaceutical companies understand and utilize preemption as a defense in product liability lawsuits in California.
Recent FDA Developments in Digital Health & Clinical Decision Support SoftwareMichael Swit
June 7, 2018 presentation at the 4th Annual Medical Device Summit, sponsored by ComplianceOnline, in San Francisco, focusing on the impact of the 21st Century Cures Act and other developments on how FDA regulates software in the medical device arena, including mobile medical applications.
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
This document provides an overview of Merck and its recalled drug Vioxx. It discusses Merck's history, leadership, stakeholders, vision, relationship with the FDA, political contributions, use of the blockbuster drug model, direct-to-consumer advertising, Vioxx's rise to fame, emerging safety concerns, and ultimate recall from the market in 2004. The recall came after studies showed Vioxx significantly increased heart attack risks. Questions remain about whether further action should have been taken against those responsible for the deaths and damages caused to consumers by Vioxx.
This document discusses the challenges and strategies for successful orphan drug development. It notes that despite small patient populations, orphan drug development has grown significantly due to regulatory incentives. However, orphan drug development faces challenges including difficulties designing studies due to lack of disease information, problems recruiting small patient populations, and regulatory complexities. The document recommends three strategies for overcoming these challenges: 1) partnering with experienced CROs knowledgeable in rare diseases, 2) engaging key opinion leaders to help with sites and education, and 3) allowing flexibility in protocols and budgets to address unexpected changes common in rare disease studies. Overall the document outlines the benefits and hurdles of orphan drug development and provides guidance on navigating clinical and regulatory obstacles.
Use of testimonials and endorsements in prescription drug advertisementsFreedom Monk
This document discusses the use of testimonials and endorsements in prescription drug advertising. It notes that while endorsements are widely used, they carry risks of being misleading if they overstate a drug's efficacy, minimize risks, or make unsupported claims. The FDA and FTC provide guidance on appropriate use of endorsements. Key points are that endorsements must be supported by substantial evidence and consistent with drug labeling. Risk information must also be adequately presented. Companies should verify endorsers' actual experience with the promoted drug. Statements cannot represent unsupported quality of life claims or overstate duration of efficacy. The FDA has taken enforcement action against misleading endorsements.
Promotional practices by pharmaceutical companies can negatively impact public health, prescribing behaviors, and trust in the industry and medical profession. Aggressive marketing has led to unsafe drugs remaining on the market longer and increased prescribing of new drugs over older generics. While codes aim to ensure promotion provides reliable and balanced information, evidence shows marketing frequently downplays risks, lacks scientific support, and inappropriately influences prescribing through gifts, trips and interactions with sales representatives. Stricter regulation and adherence to ethical standards are needed to prioritize patient well-being over commercial interests.
Dr Paul Cornes has received salary from the UK National Health Service and honoraria from several pharmaceutical companies including Roche, Janssen, Sandoz, Lilly, European Generics Association, Teva, and Hospira. The document discusses the increasing cost of cancer drugs and argues that greater use of generics and biosimilars can help contain costs while maintaining treatment effectiveness. It provides examples showing that in the US, increased generic drug use has saved over $1 trillion in healthcare costs in the past decade through lower prices.
http://www.indxx.com/indices.php?id=211 - Thus far in the 21st century, the rise of biologic drugs has been a major theme in the global pharmaceutical industry
A Pennsylvania pharmacist testified that only generic drug makers are benefiting from large price increases for generic medications. The pharmacist cited drug shortages, industry consolidation, and fewer manufacturers as reasons for the price hikes, with some generics increasing in price by as much as 8,000%. A government investigation into the sudden price increases was announced. An analysis found that more than 12,000 generic drugs have seen dramatic price rises in the last 18 months, hardest hit being patients paying out of pocket for prescriptions.
“US Orphan Drug Market Outlook 2018” research report by KuicK Research comprehensive insight on following developments related to US orphan drug market:
US Orphan Drug Market Overview
Orphan Drug Designation Criteria
Market Specific Reimbursement Policy & Regulatory Framework
US Orphan Drug Pipeline by Phase, Indication & Originator
Marketed Orphan drug List by Indication & Brand Name
Key Issue to be Resolved
Competitive Landscape
The document discusses the challenges facing the follow-on biologics (FOB) market in the United States. It states that entry into the FOB market will be more difficult than expected, as companies will face high costs of market entry, potential physician reluctance to switch patients to biosimilars, price competition from branded products, and challenges with patent litigation. However, the document predicts the FOB market will eventually emerge and flourish, though it may grow more slowly than the generic small molecule market and biosimilars are unlikely to capture as much market share as quickly. Success in the FOB market will depend on getting products to market first and having the right strategies to navigate these challenges.
Biosimilars are complex biologic drugs that are similar but not identical to innovative biologic reference products. Several key points are made:
- Biosimilars are regulated differently than small molecule generics due to biologics' larger size and more complex manufacturing processes.
- While some regulators may designate a biosimilar as interchangeable, decisions on substitution are made separately at a national or state level.
- Health Canada does not declare any drug interchangeable and leaves substitution decisions to provinces, whereas the FDA may designate a biosimilar interchangeable if it is biosimilar and switching poses no greater risk to patients.
- Automatic substitution is not recommended and interchangeability requires specifically designed clinical trials for each
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
All manuscripts are subject to rapid peer review. Those of high quality (not previously published and not under consideration for publication in another journal) will be published without delay
The Feds and Medical Cannabis: Signs Of Change or Business as Usual?Mike Bernhardt
- The National Cancer Institute acknowledged potential anti-tumor properties of cannabis but then amended its website to downplay cannabis' role in cancer treatment after media attention.
- The DEA proposed rescheduling some cannabis-based drugs but affirmed that plant-derived cannabinoids would remain Schedule I.
- Despite claims of hundreds of clinical trials, a search found very few actual clinical trials assessing smoked or vaporized medical cannabis.
1) As biologic drug sales increase, manufacturers are developing biosimilars and biobetters to maximize returns and benefit patients. Biosimilars may lower costs through competition, while biobetters aim to improve existing drugs.
2) Biosimilars are not identical to original biologics due to complex manufacturing processes, but can be approved through clinical trials demonstrating similarity. Biosimilars may save 10-35% of originator costs in Europe.
3) The US represents a major market opportunity but has not approved a regulatory pathway. Widespread biosimilar use depends on generating physician and patient confidence in quality and safety.
Merck developed the drug Vioxx to treat arthritis pain. It was approved by the FDA in 1999 but later studies showed it increased risks of heart attacks and strokes. Merck faced thousands of lawsuits and eventually paid $4.85 billion to settle claims after voluntarily withdrawing Vioxx from the market in 2004. The document discusses the history of Merck and development of Vioxx, clinical trials that showed safety issues, lawsuits against Merck, and recommendations for how the FDA could strengthen drug safety processes going forward to prevent similar situations.
Pharmaceutical globalization: Where are drugs invented?thinkBiotech
The document discusses the globalization of drug discovery and development. It examines factors that influence where research and production occurs such as workforce costs, market size, intellectual property laws, and government policies. Countries like the US and Europe have traditionally led in innovation due to strong markets and patent protection, but Asia is increasing its role with lower costs and a growing skilled workforce. Where drugs are invented is shifting over time, with the US share declining and Asia rising in recent decades.
In this presentation, Director of National Outreach Shabbir Imber Safdar reviews the current state of counterfeit drugs in America today, discusses some of the myths surrounding importation, and provides tips for saving money safely on the cost of prescription drugs.
Us biosimilars market opportunity & clinical pipeline analysisRajesh Sarma
“US Biosimilars Market Opportunity & Clinical Pipeline Analysis” Report Highlight:
US Biosimilars Market Introduction
US Biosimilars Regulatory Scenario
Unique Features of US Biosimilars Market
Impact of Biosimilars in US Market
Impact of Reimbursement Policies on US Biosimilars Market
Zarxio: First Approved Biosimilar in US
US Biosimilar Clinical Pipeline By Company, Indication & Phase
US Biosimilar Clinical Pipeline: 104 Biosimilars
Marketed Biosimilars: 1 Biosimilar
The document discusses the Indian pharmaceutical industry and the market for generic drugs. It provides background on key policies that promoted the growth of the Indian generic drug industry, including the Patent Act of 1970. It outlines the strengths and weaknesses of the Indian pharmaceutical industry. It also discusses the significant role of the Indian pharmaceutical industry in supplying generic drugs globally, particularly to regulated markets like the US. The industry is expected to continue growing and shifting to focus more on R&D and manufacturing of value-added drugs.
Managers in the pharmaceutical industry face both opportunities and threats due to a dynamic environment. Demand for pharmaceuticals has grown steadily for decades due to demographics and successful new drugs can be highly profitable. However, developing new drugs takes 10-15 years and costs $800 million on average, with many failing. Additionally, incumbent firms face challenges such as upcoming patent expirations, potential price controls, and reduced prices negotiated by large health providers.
The document is a program for an education awards ceremony honoring distinguished leaders in education. It lists the recipients of the awards, including Dr. Maya Soetoro-Ng from the University of Hawaii, Dr. Carmen Farina from the NYC Department of Education, Ernest Logan from the Council of School Supervisors and Administrators, and Dr. David Steiner from Hunter College. It provides brief biographies for each of the award recipients and outlines the program for the ceremony, including guest speakers and presentations.
Most commercial insulin assays fail to detect recombinant insulin analoguessstrumello
Most commercial insulin assays are unable to accurately detect recombinant insulin analogues. A study published in 2006 found that many insulin tests on the market fail to measure modern insulin formulations that are genetically engineered versions of human insulin. This can lead to incorrect results when monitoring insulin levels in patients taking analogues.
This document discusses the challenges and strategies for successful orphan drug development. It notes that despite small patient populations, orphan drug development has grown significantly due to regulatory incentives. However, orphan drug development faces challenges including difficulties designing studies due to lack of disease information, problems recruiting small patient populations, and regulatory complexities. The document recommends three strategies for overcoming these challenges: 1) partnering with experienced CROs knowledgeable in rare diseases, 2) engaging key opinion leaders to help with sites and education, and 3) allowing flexibility in protocols and budgets to address unexpected changes common in rare disease studies. Overall the document outlines the benefits and hurdles of orphan drug development and provides guidance on navigating clinical and regulatory obstacles.
Use of testimonials and endorsements in prescription drug advertisementsFreedom Monk
This document discusses the use of testimonials and endorsements in prescription drug advertising. It notes that while endorsements are widely used, they carry risks of being misleading if they overstate a drug's efficacy, minimize risks, or make unsupported claims. The FDA and FTC provide guidance on appropriate use of endorsements. Key points are that endorsements must be supported by substantial evidence and consistent with drug labeling. Risk information must also be adequately presented. Companies should verify endorsers' actual experience with the promoted drug. Statements cannot represent unsupported quality of life claims or overstate duration of efficacy. The FDA has taken enforcement action against misleading endorsements.
Promotional practices by pharmaceutical companies can negatively impact public health, prescribing behaviors, and trust in the industry and medical profession. Aggressive marketing has led to unsafe drugs remaining on the market longer and increased prescribing of new drugs over older generics. While codes aim to ensure promotion provides reliable and balanced information, evidence shows marketing frequently downplays risks, lacks scientific support, and inappropriately influences prescribing through gifts, trips and interactions with sales representatives. Stricter regulation and adherence to ethical standards are needed to prioritize patient well-being over commercial interests.
Dr Paul Cornes has received salary from the UK National Health Service and honoraria from several pharmaceutical companies including Roche, Janssen, Sandoz, Lilly, European Generics Association, Teva, and Hospira. The document discusses the increasing cost of cancer drugs and argues that greater use of generics and biosimilars can help contain costs while maintaining treatment effectiveness. It provides examples showing that in the US, increased generic drug use has saved over $1 trillion in healthcare costs in the past decade through lower prices.
http://www.indxx.com/indices.php?id=211 - Thus far in the 21st century, the rise of biologic drugs has been a major theme in the global pharmaceutical industry
A Pennsylvania pharmacist testified that only generic drug makers are benefiting from large price increases for generic medications. The pharmacist cited drug shortages, industry consolidation, and fewer manufacturers as reasons for the price hikes, with some generics increasing in price by as much as 8,000%. A government investigation into the sudden price increases was announced. An analysis found that more than 12,000 generic drugs have seen dramatic price rises in the last 18 months, hardest hit being patients paying out of pocket for prescriptions.
“US Orphan Drug Market Outlook 2018” research report by KuicK Research comprehensive insight on following developments related to US orphan drug market:
US Orphan Drug Market Overview
Orphan Drug Designation Criteria
Market Specific Reimbursement Policy & Regulatory Framework
US Orphan Drug Pipeline by Phase, Indication & Originator
Marketed Orphan drug List by Indication & Brand Name
Key Issue to be Resolved
Competitive Landscape
The document discusses the challenges facing the follow-on biologics (FOB) market in the United States. It states that entry into the FOB market will be more difficult than expected, as companies will face high costs of market entry, potential physician reluctance to switch patients to biosimilars, price competition from branded products, and challenges with patent litigation. However, the document predicts the FOB market will eventually emerge and flourish, though it may grow more slowly than the generic small molecule market and biosimilars are unlikely to capture as much market share as quickly. Success in the FOB market will depend on getting products to market first and having the right strategies to navigate these challenges.
Biosimilars are complex biologic drugs that are similar but not identical to innovative biologic reference products. Several key points are made:
- Biosimilars are regulated differently than small molecule generics due to biologics' larger size and more complex manufacturing processes.
- While some regulators may designate a biosimilar as interchangeable, decisions on substitution are made separately at a national or state level.
- Health Canada does not declare any drug interchangeable and leaves substitution decisions to provinces, whereas the FDA may designate a biosimilar interchangeable if it is biosimilar and switching poses no greater risk to patients.
- Automatic substitution is not recommended and interchangeability requires specifically designed clinical trials for each
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
All manuscripts are subject to rapid peer review. Those of high quality (not previously published and not under consideration for publication in another journal) will be published without delay
The Feds and Medical Cannabis: Signs Of Change or Business as Usual?Mike Bernhardt
- The National Cancer Institute acknowledged potential anti-tumor properties of cannabis but then amended its website to downplay cannabis' role in cancer treatment after media attention.
- The DEA proposed rescheduling some cannabis-based drugs but affirmed that plant-derived cannabinoids would remain Schedule I.
- Despite claims of hundreds of clinical trials, a search found very few actual clinical trials assessing smoked or vaporized medical cannabis.
1) As biologic drug sales increase, manufacturers are developing biosimilars and biobetters to maximize returns and benefit patients. Biosimilars may lower costs through competition, while biobetters aim to improve existing drugs.
2) Biosimilars are not identical to original biologics due to complex manufacturing processes, but can be approved through clinical trials demonstrating similarity. Biosimilars may save 10-35% of originator costs in Europe.
3) The US represents a major market opportunity but has not approved a regulatory pathway. Widespread biosimilar use depends on generating physician and patient confidence in quality and safety.
Merck developed the drug Vioxx to treat arthritis pain. It was approved by the FDA in 1999 but later studies showed it increased risks of heart attacks and strokes. Merck faced thousands of lawsuits and eventually paid $4.85 billion to settle claims after voluntarily withdrawing Vioxx from the market in 2004. The document discusses the history of Merck and development of Vioxx, clinical trials that showed safety issues, lawsuits against Merck, and recommendations for how the FDA could strengthen drug safety processes going forward to prevent similar situations.
Pharmaceutical globalization: Where are drugs invented?thinkBiotech
The document discusses the globalization of drug discovery and development. It examines factors that influence where research and production occurs such as workforce costs, market size, intellectual property laws, and government policies. Countries like the US and Europe have traditionally led in innovation due to strong markets and patent protection, but Asia is increasing its role with lower costs and a growing skilled workforce. Where drugs are invented is shifting over time, with the US share declining and Asia rising in recent decades.
In this presentation, Director of National Outreach Shabbir Imber Safdar reviews the current state of counterfeit drugs in America today, discusses some of the myths surrounding importation, and provides tips for saving money safely on the cost of prescription drugs.
Us biosimilars market opportunity & clinical pipeline analysisRajesh Sarma
“US Biosimilars Market Opportunity & Clinical Pipeline Analysis” Report Highlight:
US Biosimilars Market Introduction
US Biosimilars Regulatory Scenario
Unique Features of US Biosimilars Market
Impact of Biosimilars in US Market
Impact of Reimbursement Policies on US Biosimilars Market
Zarxio: First Approved Biosimilar in US
US Biosimilar Clinical Pipeline By Company, Indication & Phase
US Biosimilar Clinical Pipeline: 104 Biosimilars
Marketed Biosimilars: 1 Biosimilar
The document discusses the Indian pharmaceutical industry and the market for generic drugs. It provides background on key policies that promoted the growth of the Indian generic drug industry, including the Patent Act of 1970. It outlines the strengths and weaknesses of the Indian pharmaceutical industry. It also discusses the significant role of the Indian pharmaceutical industry in supplying generic drugs globally, particularly to regulated markets like the US. The industry is expected to continue growing and shifting to focus more on R&D and manufacturing of value-added drugs.
Managers in the pharmaceutical industry face both opportunities and threats due to a dynamic environment. Demand for pharmaceuticals has grown steadily for decades due to demographics and successful new drugs can be highly profitable. However, developing new drugs takes 10-15 years and costs $800 million on average, with many failing. Additionally, incumbent firms face challenges such as upcoming patent expirations, potential price controls, and reduced prices negotiated by large health providers.
The document is a program for an education awards ceremony honoring distinguished leaders in education. It lists the recipients of the awards, including Dr. Maya Soetoro-Ng from the University of Hawaii, Dr. Carmen Farina from the NYC Department of Education, Ernest Logan from the Council of School Supervisors and Administrators, and Dr. David Steiner from Hunter College. It provides brief biographies for each of the award recipients and outlines the program for the ceremony, including guest speakers and presentations.
Most commercial insulin assays fail to detect recombinant insulin analoguessstrumello
Most commercial insulin assays are unable to accurately detect recombinant insulin analogues. A study published in 2006 found that many insulin tests on the market fail to measure modern insulin formulations that are genetically engineered versions of human insulin. This can lead to incorrect results when monitoring insulin levels in patients taking analogues.
The document outlines the agenda for Roche's 2011 Social Media Summit, including presentations and discussions on emerging diabetes social media trends, Roche products like insulin pumps and meters, and workshops on developing ideas for engaging the diabetes community online. The summit brings together Roche representatives and guests from diabetes organizations to share insights and strategize ways to enhance digital outreach efforts.
Statement of Inger Mollerup, VP Novo Nordisk A/S for Congressional Hearings o...sstrumello
Inger Mollerup, Vice President of Novo Nordisk A/S, testified before the Government Oversight and Reform Committee about establishing a pathway for approval of follow-on biologics. She argued that any pathway must require clinical trials to demonstrate safety because even minor differences in biologics can have major health consequences, as shown through Novo Nordisk's experience. She also stated that traceability and unique names are important for pharmacovigilance, and that interchangeability is not supported by current science given potential immunogenicity differences between products.
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.
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.
This document provides an overview of the global generic pharmaceutical industry and the regulatory process for approving generic drugs in the United States. It discusses key topics such as:
1) The size and growth of the global generic market compared to the overall pharmaceutical industry.
2) How the Hatch-Waxman Act of 1984 streamlined the generic drug approval process in the US through the ANDA pathway.
3) Potential issues with the Hatch-Waxman Act around "evergreening" patents and deals between brand and generic companies that delay generic competition.
IN THIS SUMMARY
The United States Food and Drug Administration (FDA) has significant reach in the American economy, ranging from medicines and medical devices to items on the grocery store shelves. Since its inception in 1906, the agency has faced a variety of technical and political challenges. Looking ahead, the FDA faces many new demands that could enlarge the agency’s already expansive mandate. New responsibilities may include the cost of medicine, consumers’ pursuit of perfection through drugs, consumer lifestyles, tobacco, and counterterrorism. As the nature of public health changes over time, it is inevitable that the FDA’s scope and responsibilities will change as well. In Inside the FDA, Fran Hawthorne explains the history of the FDA, how its processes work, and what the future may hold for this government agency.
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http://www.bizsum.com/summaries/inside-fda
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 recommends an overweight position in the healthcare biotechnology industry. Major companies are seeing double digit revenue growth and high profit margins due to limited competition from patents. However, government regulation poses a threat if it imposes price caps or reduces patent lives. Additionally, companies rely on a small number of "star drugs" whose expiration or replacement could significantly harm their value.
Nearly 8 in 10 prescriptions filled in the U.S. are for generic drugs. The FDA requires that generic drugs have the same active ingredients, strength, dosage form and administration as the brand name drugs. Generic manufacturers must prove their drugs are bioequivalent to the brand name drugs and meet the same quality standards in manufacturing. On average, generic drugs cost 80-85% less than their brand name counterparts and saved $158 billion in 2010 alone.
Antitrust Aspects of Acquiring a Generic Drug ManufacturerNexsen Pruet
The document discusses antitrust issues related to acquisitions of generic drug manufacturers, including an overview of FTC enforcement actions challenging mergers in this industry from 1995 to present. It outlines criteria the FTC applies in their analysis, such as the impact of branded drugs on generics, delivery methods, number of competitors, and parties' innovation pipelines. The FTC takes into account these factors to determine whether a merger will reduce competition and harm consumers in generic drug markets.
In order to promote the uptake of biosimilars across the U.S., stakeholders must be informed about the basic science of these important medicines. Created out of the Biosimilars Forum's Biosimilars Roundtable (formerly the Biosimilars Forum Stakeholder Workshop group), this two page document incorporates feedback from nearly 40 stakeholder groups, from patient advocacy organizations to physician and payer groups, and presents the basic knowledge that all stakeholders need to know about the safety and efficacy of biosimilars, including answers to common myths about them.
This document summarizes the regulations and history around generic drug applications (ANDAs) in the United States. It explains that an ANDA is an application to produce a generic version of an approved drug that is the same in dosage, strength, and use. The document outlines the basic requirements for generic drugs and discusses the historical approval pathways including ANDAs, paper NDAs, and monographs that preceded the modern system established by the Hatch-Waxman Act of 1984. This law standardized the ANDA process and established provisions to balance generic competition with patent protections for brand drugs.
Pharmacovigilance Risk Management for BiosimilarsCovance
This paper focuses on pharmacovigilance (PV) and risk management for biosimilars, the issues and challenges faced in monitoring their safety and possible solutions.
This document provides an overview of biologics and biosimilars. It defines biologics as complex medications made from living cells that treat diseases in novel ways. Biosimilars are highly similar but not identical copies of biologics that are approved through an abbreviated pathway. The FDA will determine standards for interchangeability and require rigorous testing to ensure biosimilars are safely effective for each condition and patient group. Important issues for patients include ensuring safety, transparency, and choice in biologic treatment.
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.
Consumers love to save money and companies love to make it. So why do all pharmaceutical manufacturers not supply generics to the animal health industry?
This document summarizes guidelines for biosimilars in India. It begins by defining biosimilars as biologic compounds that are similar but not identical to reference biopharmaceuticals. It then discusses several biosimilar drugs used in cancer treatment such as G-CSF, interferons, and epoetins. While biosimilars have similar mechanisms of action, differences in manufacturing can result in differences in properties. The document concludes by outlining Indian regulatory guidelines for biosimilar approval and the importance of post-marketing safety monitoring to evaluate potential differences from reference drugs.
This document discusses biosimilars, which are biologic medications that are similar but not identical to an original biologic reference medication. It provides background on biosimilars and regulatory guidelines around them. Specifically, it notes that biosimilars take 6-9 years to develop compared to 3 years for generics, and that they require clinical trials to demonstrate safety and efficacy compared to the reference medication. The document also discusses biosimilar guidelines in India and examples of biosimilars used in cancer treatment, noting some differences between biosimilar versions of medications like G-CSF and interferons.
The document discusses the need for the FDA to better regulate the dietary supplements industry in order to protect public safety. It notes that the billion dollar industry is currently under less stringent regulation than the pharmaceutical industry since supplements are classified as foods rather than drugs. This could allow unsafe products to reach consumers without proper testing or oversight. The authors propose several steps for the FDA to take including implementing pre-market regulations to review products for safety, educating consumers, and increasing independent case studies to hold manufacturers accountable. The goal is to ensure supplements are reliable and consumers can make informed choices to avoid potential health issues like mortality from overuse or contaminated products.
The document discusses the need for the FDA to better regulate the dietary supplements industry in order to protect public safety. It notes that the billion dollar industry is currently under less stringent regulation than the pharmaceutical industry, despite supplements sometimes having detrimental health effects. The authors propose that the FDA implement pre-market regulations and testing of supplements, educate consumers, and conduct more case studies to hold manufacturers accountable and remove unsafe products from the market. This would help ensure that supplements are reliable and that consumers are informed of benefits and risks.
The pharmaceutical industry is defined as companies that research, develop, manufacture, and market drugs and biologicals. Key products are drugs and biologicals used to treat diseases. The top 10 pharmaceutical companies are multinational and generate over $300 billion in annual revenues. The U.S. is the largest pharmaceutical market at $300 billion, followed by Europe at $264 billion. Generics now account for over 80% of prescriptions as patents expire and government incentives shift to lower-cost drugs.
Similar to Could Generic Insulin Soon Hit the U.S. Market? (20)
Civica will manufacture and distribute biosimilar insulins at an affordable price to help the millions of Americans who struggle to afford life-saving insulin medications. They plan to produce glargine, lispro and aspart insulin and sell them for no more than $30 per vial or $55 for a box of pen cartridges. This would represent up to a 90% discount compared to current market prices and ensure no one has to ration insulin due to cost. JDRF and other organizations are partnering with Civica to help reduce healthcare disparities and make insulin universally accessible.
On March 3, 2022, the nonprofit drug company Civica Rx announced its intention to introduce 3 insulin biosimilars at list prices which promise to be below copays and cost-sharing on insulin for many insured patients, as well as much less costly for uninsured patients.
This document provides background information on Scott Strumello and his assessment of why insulin prices are so high in the US. It discusses how Strumello investigated the issue and found that while drug companies share some blame, the primary culprits are health insurance companies. Insurance companies collect large rebates on insulin but fail to pass these savings to patients, instead using the money to offer premium discounts to employers. This forces many patients to pay the full list price of insulin out of pocket due to high deductible plans. While drug companies, pharmacy benefit managers, and legislators all play a role, Strumello argues that insurance companies deserve most of the blame for the rising out-of-pocket costs that patients face.
The document contains a transcript of an online discussion between Larry Soler, Vice President of Government Relations at the Juvenile Diabetes Research Foundation (JDRF), and several participants. Soler discusses JDRF's advocacy efforts and priorities, which include expanding stem cell research policies, increasing funding for juvenile diabetes research, and increasing the availability of pancreases for islet cell transplants. He explains how JDRF utilizes volunteers and grassroots organizing to effectively lobby Congress and influence policy on issues related to diabetes research.
Spinach and Artichoke Dip (Associated Press)sstrumello
This recipe provides instructions for making a spinach and artichoke dip appetizer. It calls for Greek yogurt, cream cheese, spinach, artichoke hearts, onions, herbs, and crushed whole-grain crackers. The ingredients are combined and baked for 10-15 minutes until hot. The dip serves 8 people and each serving contains 32 calories, 2g fat, 1g protein, and 3g carbohydrates.
IDF Presentation to 2011 Roche Social Media Summitsstrumello
The International Diabetes Federation (IDF) is a global organization focused on diabetes care, prevention, and treatment. It has over 220 member associations in over 160 countries. The IDF aims to stem the growing global diabetes epidemic by advocating for policies and programs, raising awareness through events like World Diabetes Day, publishing research on diabetes prevalence and costs, and convening the global diabetes community. In the lead up to the 2011 UN Summit on non-communicable diseases, the IDF is lobbying governments to commit to national diabetes plans and increased resources to fight diabetes worldwide.
This document discusses how new diabetes technologies promise easier management but many people still struggle to maintain control or avoid burnout. While technology helps, people need breaks from the constant demands of diabetes care. The document contrasts unsafe breaks like ignoring treatment with safe breaks like occasional relaxed monitoring that don't compromise long-term health but provide needed relief. It encourages planning occasional breaks to sustain motivation and enjoying life with diabetes.
Biodel, Inc. Investor Presentation January 14, 2010sstrumello
This document summarizes a presentation given at the 28th Annual Healthcare Conference in San Francisco on January 14, 2010. The presentation was given by Biodel Inc., a company focused on developing enhanced insulin therapies for diabetes. Biodel discussed their lead product candidate VIAject, an ultra rapid-acting prandial insulin, which completed two successful Phase 3 trials and is awaiting FDA approval. The presentation provided an overview of Biodel's pipeline of diabetes programs, the insulin market opportunity, and preclinical and clinical data demonstrating VIAject's superior pharmacokinetic and pharmacodynamic profile compared to existing rapid-acting insulins.
Lola, a 2-year-old Yorkshire terrier, won first place in the "Smartest Pet in Queens" contest. She knows tricks like sit, paw down, and up, and likes to pretend fly. Princess, a mixed breed dog, came in second place. She can hold a ball in her mouth with her paws and prays without a ball. Phyllis, a half Siamese cat, took third place. She alerts her owner Scott of his juvenile diabetes episodes and ensures he is okay at night.
One of the latest success stories in diabetes research has been the development of anti-CD3 monoclonal antibodies to slow the progression of type 1 diabetes, which has been in development for over a decade. Two biotechnology companies, MacroGenics and Tolerx, are currently conducting phase III clinical trials testing different anti-CD3 drugs, with the goal of preserving insulin-producing beta cell function and reducing insulin needs. If successful, the results of these trials could provide evidence for FDA approval of anti-CD3 therapy as a treatment for newly diagnosed type 1 diabetes patients.
Stanford University Case Study: Novo Nordisksstrumello
Novo Nordisk was historically the second largest producer of insulin in the world in 1981, supplying 25% of global demand. While it dominated the European market, it held less than 5% share in the large and lucrative US market, which was dominated by Eli Lilly at 83% share. By 1995, the insulin industry had consolidated significantly due to changes in technology, regulation, and competition. Novo broadened its product portfolio and global presence but continued to trail Eli Lilly in the important US market. Managing this competitive challenge would be a focus for Novo Nordisk's leadership going forward.
Different Potencies of Biosynthetic Human and Purified Porcine Insulinsstrumello
The document summarizes research comparing the biological activity of purified porcine insulin and Biosynthetic Human Insulin (BHI) using the glucose clamp technique. The study found that:
1) BHI required significantly more glucose infusion than purified porcine insulin to maintain euglycemia, indicating BHI had higher biological activity.
2) Purified porcine insulin, but not BHI, induced significant increases in serum growth hormone and Cortisol concentrations.
3) There were no significant differences in serum insulin, glucose, or C-peptide levels between the two insulins.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
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These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
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A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
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