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Teva Pharmaceutical (Nasdaq: TEVA ) has decided it's not worth waiting for the U.S. government to establish a pathway for approval of generic versions of biologic drugs. Instead, it's asking for approval for its copycat of Amgen's (Nasdaq: AMGN ) Neupogen under the normal branded-drug process.
Generic-drug makers can get generic versions of small-molecule drugs approved through an Abbreviated New Drug Application (ANDA). Essentially, they just have to prove that their version of the drug is identical enough to the branded drug, and then the Food and Drug Administration uses the original data from the branded-drug's New Drug Application (NDA) to establish safety and effectiveness.
The NDA equivalent for biologic drugs like Biogen Idec's (Nasdaq: BIIB ) and Elan's (NYSE: ELN ) Tysabri or Abbott Labs' (NYSE: ABT ) Humira is a Biologic License Application (BLA), but Congress and the FDA never established the equivalent abbreviated application for generics -- an ABLA, if you will. Generic-drug makers like Teva and Mylan, as well as a few branded-drug makers like Novartis (NYSE: NVS ) and Merck (NYSE: MRK ) , have been waiting for years for Congress to set up an ABLA approval pathway.
It seems Teva decided not to wait any longer. Instead, the company just went ahead and submitted a BLA for XM02, its copycat of Amgen's Neupogen -- a drug that stimulates the production of a type of white blood cells in cancer patients. XM02 is already on the market in Europe, where a pathway to approve biosimilar drugs has been established for a while.
The big question is whether Teva has enough data to support an approval under a BLA. The company conducted five small clinical trials comparing XM02 to Neupogen and has data for 680 patients. By contrast, Neupogen's current label has studies covering more than 1,200 patients. Teva doesn't mention having tested XM02 in acute myeloid leukemia or severe chronic neutropenia, both of which are approved indications for Neupogen, so Teva is probably hoping that it can get away with fewer patients in exchange for a more restrictive label.
We should know in 10 months or so whether the FDA goes for it.