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 […]
AAM Applauds Senate Finance’s Meaningful Effort to Reduce Drug Prices for America’s Patients
WASHINGTON, DC (July 23, 2019) –“The bipartisan proposal from Senate Finance takes meaningful steps to increase access and reduce the cost of prescription drugs for America’s patients. We appreciate the recognition by Chairman Grassley and Ranking Member Wyden of the value provided by generics and biosimilars to the nearly 60 million seniors in Medicare. “This […]
AAM Applauds Sens. Cornyn and Blumenthal’s Efforts to Accelerate Access to More Affordable Biosimilar Medicines
WASHINGTON, DC (June 26, 2019) — We the Association for Accessible Medicines (AAM) applaud Senator Cornyn’s and Senator Blumenthal’s efforts to cap the number of later patents that can be used to block access to more affordable biosimilars. AAM believes that this is a step in the right direction to accelerating biosimilar litigation. AAM believes that capping […]
Christine Simmon Reacts to the Release of FDA’s Biosimilars Action Plan
Christine Simmon, Executive Director of AAM’s Biosimilars Council, reacts to the recent release of FDA’s Biosimilars Action Plan
AAM Issue Brief Biosimilars Medicare Part D
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 […]
AAM Statement on FDA’s Biosimilars Action Plan
Agency’s Commitment to Competition, Efficient Development and Approval Process Lauded WASHINGTON DC (July 18, 2018) – The Association for Accessible Medicines (AAM) commends the U.S. Food and Drug Administration (FDA) on its release today of its Biosimilars Action Plan (BAP), outlining a wide range of specific steps it will take to encourage the development of […]
The Biosimilars Council Congressional Briefing: Five Takeaways
Last Friday, The Biosimilars Council hosted a congressional briefing titled “Biosimilars: The Challenges and Promise of Patient Access.” AAM’s Craig Burton moderated a discussion with Molly Burich (Boehringer Ingelheim), Mark Fleury (American Cancer Society’s Cancer Action Network), Greg Gierer (America’s Health Insurance Plans) and Patrick Vallano (Mylan). View more photos from the briefing. Although the […]
