Biosimilar
A biosimilar is a biologic medicine highly similar to an already-approved reference biologic, with no clinically meaningful differences in safety or effectiveness. Because biologics cannot be copied exactly, biosimilars undergo their own approval pathway and typically offer lower-cost treatment alternatives.
What is a biosimilar?
A biosimilar is a biologic medicine that is highly similar to an already-approved reference biologic, with no clinically meaningful differences in safety or effectiveness. Because biologics are made from living systems and cannot be reproduced as identical copies, a biosimilar is closely comparable rather than an exact duplicate.
This is the key distinction from a generic version of a small-molecule drug, which can be chemically identical to its reference. A biosimilar instead matches its reference product within accepted scientific standards.
Why are biosimilars important?
Biosimilars go through their own regulatory approval pathway designed to confirm their similarity to the reference biologic. This process supports confidence in using them as alternatives once they reach the market.
By introducing competition for established biologics, biosimilars typically offer lower-cost treatment options. That can expand access and influence the choices payers and providers make about which products to use.
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