Changes Sought in Biologics Meeting Draft Guidance
Pfizer says it has publicly urged manufacturers of Biosimilar User Fee Act products not to be solely focused on similarity when meeting with FDA. It has said that sponsors should be discussing manufacturing, packaging, and filing questions with the agency as they would for any biological product. “This should be noted in the draft guidance (on formal meetings between FDA and sponsors or applicants of biosimilar user fee act products) in order to ensure visibility to manufacturers as they plan for interactions with the agency,” the company says in a comment on the draft guidance.
The letter also suggests that the agency consider developing guidance on application requirements relating to manufacturing that provides a detailed outline of expectations applicable to all biotherapeutic applications. “This level of transparency in filing expectations would enable more focused discussion with the agency during formal meetings and provide sponsors with the clarity necessary to ensure applications are complete,” Pfizer says.
In its comment letter, Lilly notes that the draft guidance says it does not apply to meetings associated with development of products intended for submission in, or with the review of, NDAs or ANDAs under section 505 of the Federal Food, Drug, and Cosmetic Act, BLAs under section 351(a) of the Public Health Services Act, or submissions for devices under the Federal Food, Drug, and Cosmetic Act. Lilly particularly calls attention to “transition products” that meet the agency’s definition of a biologic but are currently approved as drugs. It says that transition product sponsors may need to request a meeting with FDA for advice on product development issues from a biosimilar perspective. “Due to the importance of advance planning for development issues,” the company says, “it is critical that transition product sponsors have the ability to request and participate in such meetings with FDA prior to the transition date…. In light of this omission in the guidance and the need for transition sponsors to begin preparing immediately for potential development issues that will arise after the transition date, FDA should immediately clarify that transition product sponsors are eligible to request and participate in meetings on development topics related to biosimilars or interchangeable biologics, without the need to formally enter the biosimilar biological product development (BPD) program and without the need to pay a BPD fee that is duplicative of the PDUFA fees they are currently paying.”