USA – FDA Rolls Out Expectations for Biosimilars, Soon-to-Be Biologics

The US Food and Drug Administration (FDA) on Tuesday released two new draft Q&A guidance documents on biosimilar development and the deemed to be a license provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), as well as two final guidance documents on the same topics and one proposed rule amending the definition of a biological product.

The efforts are part of FDA’s decade-long work to begin, starting in March 2020, transitioning the approved marketing applications for a subset of biological products, such as insulin and human growth hormone – which were previously approved as drugs under section 505 of the FD&C Act – to be deemed to be biologics licenses.

Put simply: Certain biologics will be removed from FDA’s Orange Book on 23 March 2020 and included in the Purple Book, and all subsequent follow-on applicants will not be able to rely upon these new drug applications (NDAs) for approval but will have to win approval as biosimilars.

The final guidance also describes FDA’s plans for supplements to approved NDAs that are pending on 23 March 2020. “We intend to administratively convert these pending NDA supplements to pending BLA supplements under the PHS Act,” the agency said. Industrpreviously took issue with FDA’s intentions on the matter.

Gottlieb Comments

While highlighting the need to bring down the price of insulin, FDA Commissioner Scott Gottlieb explained at the CMS/FDA Summit in Washington, D.C. on Tuesday that the goal of the guidances and new policies is two-fold: to prevent sponsors from being able to game the exclusivity provisions and forestall biosimilar entry, and to make sure that when drugs transition into biologics, they do not receive additional exclusivities that they are not entitled to…