On January 7, an expert panel convened by the FDA recommended that the agency should approve its first biosimilar, or generic version of a biologic drug. (The biosimilar in question is Sandoz’ EP2006, slated to follow on Amgen’s Neupogen, which is used in cancer treatment.) Although the FDA does not have to follow the advice offered by its expert panels, it often does so, which suggests that biosimilars are set to rocket off the launch pad, after much preparation. The FDA, for its part, has issued guidance for companies on how to gain approval for biosimilars. Yet many complications remain, and they may yet interrupt a smooth countdown. Will companies hoping to bring biosimilars to market hit their launch windows, or will the race for less costly biologics be longer than anticipated?
What factors complicate the mission to advance biosimilars?
Missteps in the “patent dance” outlined in the Biologics Price Competition and Innovation Act might prolong legal wrangling.
Unresolved (or unsatisfactorily resolved) nomenclature issues could sow confusion. (The lack of nonproprietary names could dim awareness of biosimilar options among doctors, pharmacists, and patients.)
As-yet-unknown variants of FUD (fear, uncertainty, and doubt) circulated by those seeking to protect existing biologics, or excessively high regulatory barriers, might delay the commercialization of biosimilars.
Lower-than-expected cost savings might cool enthusiasm for biosimilars.