Biologics & Biosimilars
Biologics or biological products are medicines made from living materials through highly complex manufacturing processes and must be handled and administered under carefully monitored conditions. Biologics include a wide variety of products such as cell and gene therapies, therapeutic proteins, monoclonal antibodies and vaccines. Biologics are used to prevent, treat or cure a variety of diseases with unmet medical need including cancer, chronic kidney disease, diabetes, cystic fibrosis and autoimmune disorders.
A biosimilar is exactly what its name implies — it is a biologic that is highly similar to and has no clinically meaningful differences from an existing biologic medicine (known as a reference product) that is already licensed by the U.S. Food and Drug Administration (FDA).
Biosimilars came to fruition in the U.S. after Congress enacted the Biologics Price Competition and Innovation Act (BPCIA) in 2010. Since then, biosimilars have become an important way to bolster competition and increase options for patients. The BPCIA created an abbreviated approval pathway for biosimilars while providing 12 years of data protection following the first licensure of innovative biologics, balancing the goal of reducing costs with the need to maintain incentives for the development of new innovative biologics.
After the BPCIA, The Biosimilars User Fee Act (BsUFA) was enacted in 2012 to help provide the FDA with supplemental resources and staffing specifically to support greater consistency and predictability in the regulatory review of biosimilar and interchangeable biosimilar products.
Since enactment of the BPCIA and BsUFA, and the FDA’s first approval of a biosimilar for marketing in March 2015, a robust biosimilars market has emerged in the U.S., yielding increased competition and substantial savings for patients and the government.
As of the end of 2025, over 70 biosimilars have been approved and there are 60 biosimilars launched on the market in the U.S. competing against over 15 brand biologics. Among these launched biosimilars are the first interchangeable biosimilar products, which may be substituted at the pharmacy counter without intervention from the prescriber, similar to many generic drugs. Over the next five years, savings attributable to biosimilars are projected to exceed $180 billion, a more than four-fold increase from the last five years, with much of this savings benefiting the Part B program.
Related Resources
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16 years later: How BPCIA continues to expand competition and lower costs
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The Biosimilar Red Tape Elimination Act Provides a New Profit Source for PBMs
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The U.S. Market for Biosimilars and Biologics Medicines
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