Patent Reform | Association for Accessible Medicines
In the News - View AAM CEO Dan Leonard's blog on the essential role generic drugs play during COVID-19

Patent Reform

Roadmaps for Ensuring Patient Access to Generic and Biosimilar Medicines: Securing Sustainable Markets

This paper examines the challenges to market sustainability for generic and biosimilar medicines that have cleared the regulatory and patent hurdles to obtain FDA approval and launch into the U.S. market. It is the first in a series of AAM papers that will highlight challenges to the overall sustainability of the generics and biosimilars industry.

AAM Outlines Policy Solutions for Sustained Patient Access to Generic and Biosimilar Medicines

Association for Accessible Medicines Unveils Policy Agenda for
Biden Administration and 117th Congress
Outlines Policy Solutions to Support Long-Term Sustainability of Generic and Biosimilar Medicines

New Campaign Highlights Lifesaving Role Generic Drugs Have Played in Treatment of COVID-19
Report Series Examines Threats to Patient Access and Affordability

AAM's Karin Hessler Provides an Inside Look at the GRx+Biosims 2019 Legal Track

Karin Hessler, Assistant General Counsel at the Association for Accessible Medicines, urges attendees to add their voice to the discussion at the one essential generic and biosimilar conference of the year: GRx+Biosims 2019, November 4—6 in Bethesda, MD.

The conference legal track:

Intellectual Property & Patent Reform

AAM opposes abuses of the patent system by brand-name drug companies, and we advocate for patent reform that lends itself to timely patient access to safe, effective and more-affordable medicines for patients in the United States.

AAM: Congress Should Reject Hatch-Waxman Integrity Act of 2019

WASHINGTON, DC (February 7, 2019) —Generic and biosimilar manufacturers rely on FDA approval to operate their businesses—but the Hatch-Waxman Integrity Act requires that to get it, they must surrender their right to question the validity of suspect drug patents. The Administration and Congress have been vocal about enhancing generic and biosimilar competition to lower prescription drug prices.

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