PFNX - Pfenex: The First U.S. Forteo Biosim And A Host Of Other Biosims In Pipeline
Using the 351(k) and the 505(b)(2) pathways, Pfenex (PFNX) develops biosimilars of major drugs that are going off-patent. It is currently developing biosims for four major drugs, Forteo, Lucentis, Neulasta, and Oncaspar, which together have worldwide sales reaching almost $10bn. Last year, its lead candidate PF708-301, a combination of an rDNA peptide and a delivery device, was shown to have comparable overall profiles with Forteo (teriparatide) after 24 weeks of treatment in osteoporosis patients.
The company has filed for regulatory approval in osteoporosis for a Forteo biosim, approval should be before year-end. Forteo has major