FDA introduces expectations for biosimilars, soon to be biologics

The Food and Drug Administration (FDA) have released two new draft question and answers (Q&A) documents on biosimilar development, and the deemed to be a license provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), and two final guidance documents covering the same topics, plus one proposed rule which amends the definition of a biological product.

The guidance documents are part of the FDA’s work, which officially starts in March 2020, to transition approved marketing applications for a subset of biological products, for example 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. Therefore, some biologics will be removed from FDA’s Orange Book on 23rd March 2020, and be included in the Purple Book. 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.

For supplements that are pending on 23rd March 2020, the FDA have stated that they “intend to administratively convert these pending NDA supplements to pending BLA supplements under the PHS Act”.

New questions in the updated draft Q&A include further guidance on the nature and type of information that a sponsor should provide to support a post-approval manufacturing change for a licensed biosimilar product.

Additional new questions which the FDA have responded to include: “May a sponsor seek approval, in a 351(k) application or a supplement to an approved 351(k) application, of a route of administration, a dosage form, or a strength that is not the same as that of the reference product?” and “May a sponsor seek approval, in a 351(k) application or a supplement to an approved 351(k) application, for a condition of use that has not previously been approved for the reference product?”

The other Q&A document features Q&As on biosimilarity or interchangeability, provisions related to the requirement to submit a biologics license application (BLA) for a biological product and exclusivity.

The guidelines on the ‘deemed to be a license’ provision outline the transition period for the biologics to which the provision applies, how to identify products subject to the transition, transitioning biologics from the Orange to the Purple Book and statutory or regulatory requirements for BLAs.

The final and draft guidance documents on the “deemed to be a license” provision describe the transition period for the biologics to which the provision applies, how to identify products subject to the transition, statutory or regulatory requirements for BLAs, and transitioning biologics from the Orange to the Purple Book.

To read more about this topic and view the guidance documents, please click on the links below: