Sanofi-Aventis has filed suit to prevent a generic version of one of the company’s top selling drugs from reaching the market. In July, the FDA approved the distribution of Sandoz Inc’s generic drug designed to compete with Lovenox, Senofis $4-billion a year blood thinner. Now Sanofi is challenging the procedures by which the FDA approved the generic, and the outcome of the case may establish important precedents for how the FDA can approve biological drugs, drugs which are derived from living organisms, that generate over $40 billion in U.S. sales per year.
Sanofi has not disputed the results of the comparison test, whose results suggested that its generic version was no more dangerous than Lovenox itself, but as mentioned has objected to the FDA’s procedures. Sanofi claims that the FDA lacked the authority under the Hatch-Waxman Amendments of 1984 ,which regulate the approvals of generic drugs. This includes what types of information the FDA can require from applicants.
Both Sandoz and the FDA counter that because the drugs are biologically derived they can never be identical, meaning that they cannot be compared as purely as with other non-biological drugs. Both sides have lined up big-law firepower, with Sanofi being represented by Covington & Burling and Sandoz retaining White & Case. AARP recently warned that a win for Sandofi would create an impenetrable roadblock for future approval of generic biologic pharmaceuticals.