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.
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
This article first appeared in Chain Drug Review on January 5, 2021 as Pharmacy Outlook: Dan Leonard.
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:
Association for Accessible Medicines Statement on Senate Judiciary Committee Hearing, “Intellectual Property and the Price of Prescription Drugs: Balancing Innovation and Competition.”
WASHINGTON, DC (February 13, 2019) — With everyone from patients to the President demanding action on drug pricing, AAM welcomes the re-introduction of the Preserving Access to Cost Effective Drugs (PACED) Act.
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.
WASHINGTON, DC (October 17, 2018)–Yesterday the Association for Accessible Medicines (AAM) filed an amicus brief in the Supreme Court case Helsinn v. Teva calling on the court to reject one form of patent system manipulation attempted by a brand-name drug company. The case will be heard on December 4.
The U.S. Food and Drug Administration (FDA) plays a critical role in keeping Americans healthy. When it comes to drug approvals, the FDA’s scientists and regulators strive every day to keep pace with the most current advances in science so that patients can benefit from innovative, safe, and effective medicines.