FDA is declining to rule out the possibility that the Sec. 505(b)(2) process could be used to allow expedited approval of follow-on biologic projects.

In an Oct. 14 response to a citizen petition submitted by the Biotechnology Industry Organization, FDA said it will not change its position that the 505(b)(2) process could be used by sponsors to obtain approval of products like human growth hormone or insulin.

However, ¹ FDA's response is explicitly limited to legal and regulatory questions. "The unique scientific issues associated with biologically derived products present a separate set of challenges that will be addressed in a response to be issued later," FDA said.

BIO's petition urged FDA to refrain from approving any application for a therapeutic protein product that "relies on information contained in another applicant's application" (² Also see "BIO Petition Opposes Generic Insulin, HGH; Asks FDA To Open Public Debate" - Pink Sheet, 28 April, 2003., p. 13).

FDA, however, responded to the BIO petition (and separate petitions submitted by Pfizer and Apotex) with a clear declaration that the regulations allow such applications (see ³ Also see "FDA 505(b)(2) Policy Affirmed; Any Changes Will Be Too Late For Norvasc" - Pink Sheet, 20 October, 2003. ).

BIO also asked FDA to refrain from issuing any new guidance concerning 505(b)(2) applications for human growth hormone and insulin, and withdraw a 1999 draft guidance on the 505(b)(2) process that the association maintains creates "new law" allowing follow-on biologic approvals.

"FDA has never relied on the 1999 draft guidances as law; the guidance merely seeks to make explicit and transparent the ways in which FDA has interpreted the law set out in the statute and regulation," the agency replied.

"The public had the opportunity to comment on the proposed regulations when they were issued and declined to do so; BIO cannot reasonably argue that additional public process is required before this regulation is implemented," FDA said.

However, the agency has pledged that the development of guidances specific to products like insulin and hGH will include further public participation (⁴ Also see "Generic Biologics On FDA Fast Track?: “Follow-On” Process Under Debate" - Pink Sheet, 26 May, 2003., p. 9).

Generic Biologics: 505(b)(2) Route Still Open, But Scientific Issues Unresolved

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