FOBs on the ground

Documents released in connection with Sandoz Inc.'s Australian launch of Omnitrope somatropin human growth hormone and FDA's recent approval of a recombinant form of human hyaluronidase may have burned off some of the fog cloaking follow-on biologics in the U.S.

In particular, FDA's approval of Halozyme Therapeutics Inc.'s Hylenex spreading agent suggests that policy on follow-on biologics continues to be created by facts on the ground, even if the agency has not released long-promised guidance on FOBs, and while both sides in lawsuits over FOBs await for their day in court...