By Kim Coghill
WASHINGTON ¿ Biotechnology companies likely won¿t have to worry anytime soon about facing the challenges met recently by Indianapolis-based Eli Lilly & Co. as its popular drug, Prozac, became fair game for generic competitors.
Prompted by questions from Sen. Orrin Hatch (R-Utah), the Washington-based Biotechnology Industry Organization Friday said that based on current science, it is not possible to establish a generic policy for biotechnology products.
The 1984 Hatch-Waxman Act established a generic policy for drugs, not biologics. ¿The question has been raised by Sen. Hatch and others as to whether or not a similar policy can be crafted for biotechnology products,¿ Stephan Lawton, BIO¿s vice president and general counsel, told BioWorld Today. ¿Based on the current science ¿ no. Biological products made by different manufacturers many times have different clinical results. They are heavily dependent on the manufacturing process. The most important part of a drug is what it¿s made of; the most important part of a biologic is how it is made.¿
BIO released a statement saying experience shows that even small product differences can result in significant safety or efficacy differences. ¿Therefore, in the current state of scientific knowledge and technique, a clinical trial remains the principal means by which the safety and effectiveness of a biotechnology product can be evaluated.¿
Pharmaceuticals are made of easily synthesized small molecules, as opposed to biologics, which consist of large molecules. The FDA does not require clinical trials on pharmaceutical generics. Currently, there are no biologics at the generic stage.
¿Sen. Hatch has asked our position on it and certainly it is a reasonable issue to debate on Capitol Hill and we look forward to that debate,¿ Lawton said.
BIO said approval of follow-on biotechnology products must be based on the same rigorous standards applied by the FDA for the approval of pioneer biotechnology products.