Top 10 Ways to Commemorate 10 Years of Biosimilars in the U.S.

U.S. biosimilar medicines are 10 years old this year. It’s been an amazing journey so far, and we see great promise and opportunity ahead, with greater access and lower prices for patients with cancer, Crohn’s disease, rheumatoid arthritis and other conditions. Here are 10 ways to mark this auspicious anniversary: 10. Learn more about the […]

AAM Commends Introduction of the Increasing Access to Biosimilars Act

WASHINGTON, DC (July 2, 2020) — AAM and its Biosimilars Council commend Senators Cornyn and Bennet for introduction of the Increasing Access to Biosimilars Act. This bipartisan proposal is based on a simple idea – that Medicare policies should encourage the use of the most effective, lowest-cost medicine. Biosimilars consistently deliver savings compared to high-priced […]

Biosimilars Handbook

The New Frontier for Improved Access to Medicines: Biosimilars & Interchangeable Biologic Products Biosimilars hold the key to ensuring affordable access to biologic medicines for all consumers. The Biosimilars Council exists to educate, advocate, and promote the development of these products through resources such as this handbook. This handbook is designed to be a reference […]

White Paper Part 2: Failure to Launch: Barriers to Biosimilar Market Adoption

America’s health care system is eager for biosimilars, especially in light of mounting evidence that they deliver increased patient access and savings by providing competition for costly brand-name biologics. Biosimilars are lower-priced versions of brand medicines that have been projected to save as much as $54 billion over the next 10 years for a range […]

2019 Generic Drug and Biosimilars Access & Savings in the U.S. Report

Overview To view the latest data, view 2020 Access & Savings Report 2019 Generic Drug and Biosimilars Access and Savings in the U.S. The 11th annual edition of AAM’s Savings and Access Report quantifies how much money American patients and our health care system are saving because of generic and biosimilar alternatives to brand-name prescription […]

Policy Recommendations to Develop a Robust Biosimilars Market in the U.S.

Biosimilars have the potential to improve quality of life for patients. If the right policies are put in place to cultivate a robust market, an additional 1.2 million patients will have access to biologic medicines, while also saving an estimated $54 billion over the next 10 years. Congress must continue working with CMS and the FDA […]

AAM Statement on FDA Draft Guidance on Biosimilar Naming Requirements

WASHINGTON, DC (March 7, 2019) – “AAM is reviewing the FDA’s new draft guidance on biosimilar naming requirements and will submit comments to the docket. FDA’s current requirement of suffixes presents a significant, artificial barrier to biosimilars that is misaligned with the agency’s own Biosimilars Action Plan and the Trump administration’s commitment to lowering drug […]

Generic and Biosimilars Approvals Are Only Half the Story

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. The FDA continues to work […]