3 Challenges to Patents on Therapeutic Monoclonal Antibodies
Three developments may have effects on the use of patents to fend off competition for therapeutic monoclonal antibodies.
Generic Drugs
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Read more: 3 Challenges to Patents on Therapeutic Monoclonal Antibodies -
Read more: AbbVie Wins First Round in Humira Antitrust Lawsuit AbbVie Wins First Round in Humira Antitrust Lawsuit
The purpose of the secondary patent filings was to assemble a thicket of patents, 132 in all, to prohibit competition from biosimilar companies.
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Read more: Monthly Round-Up of What to Read on Pharma Law and Policy Monthly Round-Up of What to Read on Pharma Law and Policy
Selections feature topics ranging from political pressures facing the FDA, to the financial incentive structure for antibiotic development.
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Read more: Monthly Round-Up of What to Read on Pharma Law and Policy Monthly Round-Up of What to Read on Pharma Law and Policy
Interesting empirical studies, policy analyses, and editorials on health law and policy issues from July 2020.
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Read more: To Cut Prescription Drug Spending, Stop Delays for Generic Competition To Cut Prescription Drug Spending, Stop Delays for Generic Competition
While generic competition is crucial for reducing drug prices, brand-name drug manufacturers can utilize several strategies to delay such competition.
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Read more: The Rise of Biosimilars: Success of the BPCIA? (Part III) The Rise of Biosimilars: Success of the BPCIA? (Part III)
By Jonathan Darrow This is Part III in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already approved biological medicines. Part III considers a path forward in the regulation of biologics. For Part I, click here. For Part II click here….
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Read more: The Rise of Biosimilars: Success of the BPCIA? (Part II) The Rise of Biosimilars: Success of the BPCIA? (Part II)
By Jonathan Darrow This is Part II in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already approved biological medicines. Part II covers some key considerations and factors that impact the biologics market and regulation. For Part I, click here. Reference…
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Read more: The Rise of Biosimilars: Success of the BPCIA? (Part I) The Rise of Biosimilars: Success of the BPCIA? (Part I)
By Jonathan Darrow This is Part I in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already-approved biological medicines. This Part briefly covers the history of American regulation of biologics and touches briefly on the European experience. The Biologics Price Competition…
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Read more: Monthly Round-Up of What to Read on Pharma Law and Policy Monthly Round-Up of What to Read on Pharma Law and Policy
By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, and Aaron S. Kesselheim Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division. Below are the abstracts/summaries…
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Read more: Monthly Round-Up of What to Read on Pharma Law and Policy Monthly Round-Up of What to Read on Pharma Law and Policy
By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, and Aaron S. Kesselheim Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division. Below are the abstracts/summaries…
