BIO SUBMITS COMMENTS TO FDA ON ABBREVIATED APPROVAL PROCESS
The Biotechnology Industry Organization (BIO) has not relaxed its position regarding an abbreviated approval process for generic biologics, despite comments in a recent docket submission to the FDA that appear to indicate some softening on the topic, according to a representative of the trade group.
In a document submitted to the FDA last month, BIO said it might support an abbreviated approval process in the future for generic versions of certain biologic protein products. That stance appears to differ from the one BIO has taken in the past, including in October 2003 when the organization argued that an abbreviated approval process for generic biologics was not possible.
"As knowledge about protein products increases and analytical testing methods evolve, and if legal and policy issues are resolved, BIO thinks that an abbreviated process may be possible in the future for certain protein products," BIO said in the second page of its Dec. 13, 2004, submission to the FDA. The group's comments were submitted at the request of the FDA, which in September 2004 issued a call for public comments on scientific considerations related to follow-on biologics.
Despite what appears in the docket submission, Michael Werner, chief of policy for BIO, said the comments do not represent a relaxing of BIO's position and that the organization's view has been and continues to be that "the science doesn't exist [for follow-on biologic approval] without manufacturers supplying full data sets through clinical trials."