FDA Releases Long-Awaited Guidances on Biosimilar Price Competition and Innovation Act

The US Food and Drug Administration (FDA) today released long-awaited guidance on the Biosimilar Price Competition and Innovation Act (BPCI) that was passed in 2010 as part of the Patient Protection and Affordable Care Act (PPACA). The draft guidance deals with interchangeability, how to submit a Biologics License Application (BLA) and biosimilar exclusivity.

The BPCI created a pathway for the approval of biosimilars in 2010, and FDA has been working on the guidance since then.

According to FDA, the BPCI included, among other things:

a 12-year exclusivity period from the date of first licensure of the reference product, during which approval of a 351(k) application referencing that product may not be made effective (see section 351(k)(7) of the Public Health Service (PHS) Act); 
a four-year exclusivity period from the date of first licensure of the reference product, during which a 351(k) application referencing that product may not be submitted (see section 351(k)(7) of the PHS Act);
an exclusivity period for the first biological product determined to be interchangeable with the reference product for any condition of use, during which a second or subsequent biological product may not be determined interchangeable with that reference product (see section 351(k)(6) of the PHS Act);
an exclusivity period for certain biological products for which pediatric studies are conducted in accordance with a written request (see section 351(m) of the PHS Act);
a transition provision for biological products that have been or will be approved under section 505 of the FD&C Act (21 U.S.C. 355) before March 23, 2020 (see section 7002(e) of the PPACA); and
a provision stating that a 351(k) application for a biosimilar product contains a "new active ingredient" for purposes of the Pediatric Research Equity Act (PREA) (see section 505B(n) of the FD&C Act).

The guidance indicates that sponsors of a product should meet with FDA early on in the development process to discuss the product, the manufacturing process information associated with the product and preliminary comparative analytical data for the product.

Biosimilar products will be allowed to have different formulations from the reference product in some instances, and minor differences in the clinically inactive components are also acceptable. The mechanism of delivery may also be different than that of the originator product in some instances, provided the sponsor can prove the performance equivalence. FDA notes that some additional data may be necessary to prove this similarity.

Sponsors may also obtain licensure for their product for fewer routes of administration than the original reference product provided the sponsor can prove there are no clinically meaningful differences.

Sponsors may also use comparative animal or clinical data with a non-US-licensed product to support a demonstration of biosimilarity. At least one pharmacokinetic or pharmacodynamics study needs to be conducted on a US-licensed product, however.

The draft guidance also addresses how to compare the strength of a biosimilar product to its reference product. FDA notes that it expects the biosimilar product to have the same total content in mass and the same concentration of drug substance as the reference products.

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