While Europe continues to make progress in approving biosimilar biologics, the US has work to do to keep pace, says Paul Calvo.
Approval of biosimilar biologics continues to be a topic of great interest as the push for accessibility to cheaper biologic medicines continues. Globally, the clear leader in the area is the European Medicines Agency (EMA), with the US Food and Drug Administration (FDA) lagging considerably behind. To look at these contrasting situations, one may think that Europe is taking one step forward, while the US takes two steps back.
The wait for approval of a biosimilar biologic goes on in the US. Since passage of the Patient Protection and Affordable Care Act on March 23, 2010, the FDA has been in the process of implementing an abbreviated licensure pathway for biosimilars. The FDA released several draft guidance documents related to the approval pathway in February 2012.
These guidance documents dealt with (1) scientific considerations in demonstrating biosimilarity to a reference product; (2) quality considerations in demonstrating biosimilarity to a reference protein product; and (3) questions and answers regarding implementation of the Biologics Price Competition and Innovation Act of 2009, aka the Biosimilars Act.
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Biosimilars, biologics, Biosimilars Act, FDA, SB-598
