Sanofi-Aventis’ suit against FDA seeking to overturn its approval of generic Lovenox is an example of what FDA will face once it approves follow-on biologics. Lovenox is not a biologic, however, it is a complex compound that raises some of the same issues as biosimilars. Chad Landmon, Partner at Axinn, told The Pink Sheet, “I think similar arguments will be litigated with respect to follow-on biologics. One of the initial disputes at FDA and in the courts [will be whether a biologic] molecule is so large we don’t know what the innovator product is.”

The article, titled “Lovenox Lawsuit May Be Omen For Biosimilar Battles,” was filed August 2, 2010, by The Pink Sheet