FDA is planning to release a draft guidance on follow-on biologics in the spring.

The guidance outlining FDA requirements for the applications of follow-on (or "generic") biologics is expected to be completed by late March or early April.

The guidance is expected to delineate what studies should be conducted for a follow-on biologic application as well as include a list of off-patent biologics for which a follow-on could be approved.

FDA has previously discussed the use of existing pathways for the approval of follow-on products to insulin and human growth hormone.

In a response to a citizen's petition from the Biotechnology Industry Organization, FDA maintained that it would retain its stance that the 505(b)(2) pathway could be used by sponsors to obtain approval of products like insulin or HGH (¹ Also see "Generic Biologics: 505(b)(2) Route Still Open, But Scientific Issues Unresolved" - Pink Sheet, 20 October, 2003., p. 8).

The draft guidance is also expected to address the extent to which applications for follow-on biologics can reference studies conducted by the manufacturer of the source biologic.

Other topics likely to be covered by the guidance include the interchangeability of follow-on biologics with the source biologic and testing requirements for the comparability of follow-on biologics.

The draft guidance is being developed by an FDA working group chaired by Center for Drug Evaluation & Research Director Janet Woodcock, MD.

The working group was formed in November and includes representatives from the Office of the Commissioner, CDER, and the biologics center, with staff focusing on chemistry, manufacturing and controls, legal, medical, and pharmacology/toxicology.

Woodcock's leadership provides the working group with a significant level of support. Woodcock began serving a six-month detail to the Office of the Commissioner in October. The scope of her responsibilities, however, indicate that the role will evolve into a more permanent position (² [A#00650410001], p. 3).

FDA Follow-On Biologics Guidance Due In Spring; Woodcock Leads Effort

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