Becker's Healthcare October 11, 2024
The Biologics Price Competition and Innovation Act of (BPCI Act) of 2009 granted responsibility to the FDA for review and approval of a new class of pharmaceuticals referred to as “Biosimilars.” (1)
The first biosimilar was approved and introduced by the FDA in March of 2015 to combat high prices associated with its competitive “Branded Reference Biologic”, and since then, 56 additional agents have been approved. Their release has prompted questions, comparisons, and confusion regarding as to their place in day-to-day clinical practice. The following article will address these questions as well as the barriers in their way for general usage.
What is a biosimilar?
Unlike traditional medications, which are derived from chemicals the class of drugs referred to as...
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