Copyright 2015 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
In March 2015, the US Food and Drug Administration (FDA) approved the first biosimilar in the United States, ushering in the age of biosimilar competition for biologics. A biosimilar is defined by the FDA as “[a] product that is highly similar to a US-licensed reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.”1 The FDA requires that a biosimilar product deliver the same dosage and strength as the reference product and be used for the same indications as the reference product. The approval of biosimilars was authorized by the Biologic Price Competition and Innovation Act (BPCIA), which is part of the Affordable Care Act.2 It allows biosimilar manufacturers to file an abbreviated application using the original producer’s data, provided that this producer has had at least 12 years of data exclusivity.2
Chandra A, Vanderpuye-Orgle J. Competition in the Age of Biosimilars. JAMA. 2015;314(3):225-226. doi:10.1001/jama.2015.6170