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

Regulatory NewsRegulatory News | 11 December 2018 |  By 

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. Industry previously 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.

In addition to the guidance documents and proposed rule, Gottlieb explained that FDA is issuing notice of how it will – upon request – review study protocols submitted by biosimilar applicants to assess whether their protocols contain comparable safety protections to those in the risk evaluation and mitigation strategy (REMS) for the reference product they’re trying to reference – as explained in the revised draft Q&A on biosimilar development and the BPCI Act.

“If requested, the FDA will issue a letter to the reference product holder informing them that comparable protections exist, and that the FDA won’t consider it to be a violation of the branded drug company’s REMS to provide the biosimilar sponsor with a sufficient quantity of the reference product to perform testing necessary to support its biosimilar application,” Gottlieb said.

Rule and Guidance

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

Other new questions, which the agency responded no 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 numerous questions and answers on biosimilarity or interchangeability, provisions related to the requirement to submit a BLA for a biological product and exclusivity.

The final and draft guidances on the “deemed to be a license” provision spell out 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.

The proposed rule, meanwhile, would amend FDA’s regulation that defines “biological product” to make a technical revision and to conform to the statutory definition enacted in the BPCIA.

New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2)

Questions and Answers on Biosimilar Development and the BPCI Act

The “Deemed to be a License” Provision of the BPCI Act Questions and Answers: Draft Guidance for Industry

Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009

Definition of the Term “Biological Product” 


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