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Biosimilar

A biosimilar is a biologic medication that is highly similar to a biologic medication already approved by FDA, known as the original biologic or reference product[1]. Biosimilars also have no clinically meaningful differences from the reference product[1].

Biologics are made from natural and living sources, such as animal and plant cells and microorganisms like bacteria or yeast[1]. Because most biologics are made from living sources, they cannot be copied exactly, which is why biosimilars are not identical to the original biologic[1].

The FDA gained the authority to approve biosimilars under the Biologics Price Competition and Innovation Act of 2009[2]. Biosimilars are approved through an abbreviated pathway that avoids duplicating certain costly clinical trials[1]. Reference to the original product is an integral component of the approval[3]. For approval, studies must show that there are no differences in the safety and effectiveness of the biosimilar and the original biologic[1].

An interchangeable product is a biosimilar that may be substituted without consulting the prescribing doctor, because it meets additional requirements related to automatic substitution[1]. Biosimilars may be available at a lower cost than the original biologics[1]. This is partly because manufacturers rely on the FDA's finding that the original biologics are safe and effective[1].

Related: Biologics License Application (BLA), EMA marketing authorisation