Biosimilars Council

The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), advocates for increased patient access to affordable biosimilar medicines in the US. Biosimilars are medicines derived from living cells that are highly similar to and have no meaningful clinical difference from previously approved biologics. These medicines are used to treat various diseases, including cancer, rheumatoid arthritis, and irritable bowel disease. The council represents manufacturers and stakeholders working to develop biosimilar medicines for the US market. In June 2024, the Biosimilars Council published a position paper outlining the benefits of updating the existing Food and Drug Administration (FDA) regulatory process for biosimilar medicines. The proposed changes aim to eliminate unnecessary regulatory requirements when data demonstrates no clinically meaningful difference between the biosimilar and its biologic reference product. Since 2015, biosimilars have been used in nearly 700 million days of critical patient therapy and have saved US patients and the healthcare system approximately USD 24 billion. Generic and biosimilar medicines represented 90% of prescriptions filled but less than 18% of spending in the US healthcare system, with savings of USD 408 billion in 2022 alone.

Key customers and partnerships

The Biosimilars Council works with various stakeholders in the healthcare sector, including patient advocacy groups. The council collaborates with public and private stakeholders to advance global and domestic health policy initiatives related to biosimilars. Additionally, the organization partners with other regulatory authorities to establish global comparators for biosimilar development and approval processes.