The Biosimilars Council, a division of the Association for Accessible Medicines, is an organization dedicated to improving access to safe, quality, effective medicines. The Biosimilars Council works to ensure a positive regulatory, reimbursement, political and policy environment for biosimilar products.
Since its establishment in 2015, the Biosimilars Council has focused on issues facing the biopharmaceutical industry, including education, patient access, the regulatory and reimbursement environment, federal and state legislation and legal affairs. Since the first biosimilar launch in 2015, patients and the healthcare system have saved nearly $36 billion. Additionally, biosimilars have been used in almost three billion days of patient therapy. However, regulatory and market barriers to entry are slowing biosimilar uptake. This means millions of patients are missing out on the incredible benefits of biosimilar medicines.
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Biosimilars have a proven ability to compete with brand name biologics, providing patients with more options for their care and lowering drug prices. Despite patients’ reliance on these vital medicines, biosimilars face significant challenges that threaten patients’ access to care and billions in savings for them and their families.
Biosimilar and brand-name biologic products manufacturing is different from manufacturing small molecule drugs, like generics.
An interchangeability designation is a unique form of regulatory review used in the United States and is not an indication of superior quality.
FDA-approved biosimilars have no clinically meaningful difference from the brand name product upon which they are based. However, brand-name manufacturers have tried to confuse patients about biosimilars’ uses and benefits.
Patent thickets are an anticompetitive practice used to prevent or delay the launch of biosimilars, increasing costs for patients and reducing their options for care.
State lawmakers can take meaningful action to lower prescription drug costs and increase patient access to biosimilars.
Learn how the Council is advocating to increase patient access to life-altering, low-cost biosimilar medicines.
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