FDA seeks to accelerate pace of biosimilar drug approvals

Kevin Noonan, a partner with McDonnell Boehnen Hulbert & Berghoff, provides commentary on the US Food and Drug Administration's (FDA) Biosimilars Action Plan in an Expert View piece.

After an uncharacteristic period of delay (at least compared with Europe), the USA enacted a biosimilar approval pathway entitled the Biologics Price Competition and Innovation Act (BPCIA) as part of the Affordable Care Act (Obamacare) in 2010.

The act was put at risk with the Supreme Court challenge in  National Federation of Independent Business v. Sebelius, 567 US 519 (2012) (because the biosimilars provisions were not severable from the challenged portions of the act), but Chief Justice Roberts’ majority opinion affirming the constitutionality of the act preserved the pathway and permitted the FDA to continue to develop regulations to put it into practice.