Biologics, Biosimilars, FDA, Regulatory

FDA rolls out expectations for a looming regulatory shift for insulin and other biologics

Certain biologics will be removed from the 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 for approval but will have to win approval as biosimilars under new proposed rules on biosimilar development.

The agency 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 the 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.

The final guidance also describes the FDA’s plans for supplements to approved NDAs that remain 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 the 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 DC on Tuesday that the goal of the guidances and new policies is two-fold: to minimize sponsors’ ability 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 the 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 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.


Image: Scott Gottlieb SHUTTERSTOCK

First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email news@raps.org for more information.


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