Mylan (MYL) and Allergan (AGN) have been locked in a battle over dry eye regimen Restasis for quite some time. Mylan, Teva (TEVA) and others want to offer a generic version and Allergan has thwarted them at every turn. That could change after the FDA recently denied Allergan’s third petition to block generic Restasis:
The Food and Drug Administration has blocked Allergan’s latest attempt to stave off generic competition to Restasis, rejecting a citizen petition filed by the company last August that challenged the regulator’s approach to approving copycat versions of the blockbuster eye drug.
Allergan’s petition, its third for generic Restasis, questioned whether competitors could use in vitro testing to adequately demonstrate bioequivalence with the branded product. Draft guidance from the FDA would allow generic companies to use either in vitro or in vivo testing to secure approval of Restasis copies.
The FDA decision received little attention last week. Allergan announced price increases of more than 9% on several drugs, which created a buzz. Over the next few weeks I expect the recent FDA action to get more attention from both MYL and AGN investors.
