The Biosimilars Council and AAM Applaud Senate Markup and Committee Passage of the Expedited Access to Biosimilars Act

The statue of George Washington taken inside the U.S. Capitol Building Rotunda

Legislation codifies FDA’s science-based approach to biosimilar review by limiting comparative efficacy studies; Introduced and Passed House Committee This Week WASHINGTON (July 23, 2026) — The Biosimilars Council and the Association for Accessible Medicines today thanked the Senate HELP Committee for marking up and passing the Expedited Access to Biosimilars Act. This legislation will codify […]

The Biosimilars Council and AAM Laud House Markup of Expedited Access to Biosimilars Act and Biosimilars Red Tape Elimination Act

US Capitol in Washington DC

Legislative progress codifies FDA’s science-based approach to biosimilar review by limiting comparative efficacy studies; Eliminates arbitrary distinction between interchangeable biologics and biosimilars WASHINGTON (July 21, 2026) — The Biosimilars Council and the Association for Accessible Medicines today lauded legislative progress as the House Energy and Commerce Committee marked up and voted to approve the Expedited […]

The Biosimilars Council and AAM Applauds House Introduction of the Expedited Access to Biosimilars Act

Legislation codifies FDA’s science-based approach to biosimilar review by limiting comparative efficacy studies WASHINGTON (July 15, 2026) — The Biosimilars Council and the Association for Accessible Medicines today applauded legislation, the Expedited Access to Biosimilars Act, introduced this week in the U.S. House of Representative by Congressman Nick Langworthy (NY-23) and Congresswoman Kim Schrier, M.D. […]

AAM and the Biosimilars Council Applaud FDA Announcement on Biosimilars Clinical Efficacy Studies and Interchangeability

FDA headquarters

FDA Commissioner Makary joined AAM’s GRx+Biosims 2025 conference today WASHINGTON (October 29, 2025) — The Association for Accessible Medicines, the trade association representing America’s manufacturers of generic and biosimilar medicines, and its Biosimilars Council, today applauded the announcement by the Food and Drug Administration to streamline approval processes for biosimilar medicines. FDA Commissioner Makary spoke […]

Generic and Biosimilar Medicines Save $467 Billion in 2024

90% of all prescriptions filled, yet only 12% of the spending, affordable medicines face severe sustainability challenges in the U.S. WASHINGTON, DC (September 3, 2025) – The Association for Accessible Medicines and the Biosimilars Council today released the 2025 U.S. Generic & Biosimilar Medicines Savings Report. AAM’s annual savings report highlights that generic and biosimilar […]

Medicare Drug Price Negotiation has Chilling Effect on Generic and Biosimilar Medicines Development and Availability

Matrix Global Advisors White Paper: Long-Term Effects of Medicare Drug Price Negotiations

Matrix Global Advisors analysis shows quantifiable negative impact and a less competitive marketplace with potential lost savings of billions per year WASHINGTON (July 14, 2025) — The Association for Accessible Medicines today commented on a white paper released by Matrix Global Advisors, Long-Term Effects of Medicare Price Negotiations on Drug Competition, which analyzes the impact […]

Patent Thickets and Litigation Abuses Hinder all Biosimilars

White paper analyzes problems and solutions to patent abuses WASHINGTON (July 8, 2025) — The Association for Accessible Medicines and its Biosimilars Council today released a white paper, Anatomy of a Biosimilar Patent Litigation: Problems and Solutions. The paper explains and illustrates the significant challenges biosimilars and generics face due to brand drug patent thickets, […]

Member Spotlight: Biocon Biologics

Investment, Innovation, Growth and Affordability Biocon Biologics has emerged as a leading biosimilars player in the U.S. and worldwide, providing innovative and more affordable ways to treat diabetes, cancer, and autoimmune diseases. As a fully integrated biosimilar company, it is singularly focused on the development, manufacturing, distribution, and commercialization of the highest quality biosimilars in […]

Pharmacy Benefit Managers Are Blocking Patient Access to Biosimilar Insulin

Blog originally released by the Biosimilars Council Just two weeks ago, the U.S. biosimilars industry entered a new phase when eight biosimilar versions of Humira launched with prices reaching as low as 85 percent below the brand list price. Humira is the bestselling drug in the U.S., and new biosimilar competition represents a major expansion […]

AAM’s Erica Klinger speaks with Connor Nell and Brian Biehn from AmerisourceBergen #GBW2022

It’s the third-annual Global Biosimilars Week, a social media campaign created and driven by the International Generic and Biosimilar Medicines Association (IGBA) and its members to raise awareness about biosimilar medicines. In conjunction with this weeklong campaign, Erica Klinger, Senior Director of Marketing at the Association for Accessible Medicines (AAM) and Chair of the 2022 […]