FDA timetable for biogenerics framework

FDA is developing a scientific framework for the regulation of follow-on biologics and expects to release a draft for public comment in the second quarter, according to a senior FDA official. The document will focus on the scientific basis for evaluating the safety and efficacy of follow-on biologics, not legal issues. It will, however, lay out a framework that FDA believes could allow approval of versions of biologics that are regulated under the Public Health Act - i.e., those marketed under BLAs - as well as those regulated as drugs.

The draft will fulfill a commitment FDA made in an October 2003 response to citizen petitions challenging its authority to approve biogeneric versions of biologics that are regulated as drugs. In addition to asserting its legal authority to approve such biogenerics under section 505(b)(2) of the Food, Drug and Cosmetic Act, FDA stated in October that "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" (see BioCentury, Oct. 20, 2003). ...