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FDA Seeks More Data on Teva Copy of Amgen's Neupogen
By THOMAS GRYTA
NEW YORK--The U.S. Food and Drug Administration declined to approve Teva Pharmaceutical Industries Ltd.'s application to sell a copycat version of Amgen Inc.'s Neupogen, effectively delaying any launch of the company's first generic biotech drug sold in the U.S.
The Israel-based generic drug giant said the FDA requested several bits of additional information but didn't require additional clinical trials to complete its review. The application for the drug, called Neutroval, was filed using a traditional approval pathway for a biologic drug, but it is sold as a biosimilar to Neupogen in Europe under the name TevaGrastim.
The delay may show the complexity of getting such medicines to market, including the scrutiny coming from regulators. Teva's FDA submission, originally made in November, included results from five studies of the drug. It was approved in Europe in September 2008.
A Teva pokeswoman declined to comment beyond the company's statement that said it "will work with the FDA to determine the appropriate next steps" for the application. Amgen officials weren't immediately available for comment.
Biosimilars are as close to a generic version as is possible for complex biologic drugs. Although a regulatory pathway for their approval in the U.S. was included in the March health-care overhaul, the FDA has yet to issue formal guidance on that pathway.
Rather than wait, Teva filed for approval using a traditional application route with supporting clinical data and has said it will do the same with other biosimilar products.
Meanwhile, Amgen has filed a patent-infringement claim in federal court to block the move. A trial date hasn't yet been set, and Amgen is widely expected to file for an injunction to block any launch by Teva if the FDA approves the drug.
Neupogen, which is used to prevent infections in chemotherapy patients, brought Amgen U.S. sales of $901 million in 2009. The company had total product sales of $14.4 billion last year.
The main European patents on Neupogen expired in 2006, allowing the sale of biosimilars, but Amgen has U.S. patents covering the drug until 2013.
Approval of Neutroval would be the first biosimilar challenge for a U.S. biotech company on native soil, providing some insights into the market's receptiveness to such products.
Like biosimilars in Europe and those expected in the U.S., Neutroval would be a branded generic. That means it couldn't be substituted like a traditional generic and would be actively marketed by Teva.
Amgen has played down the effect of biosimilar Neupogen on the market where it is sold, noting that the use of the drug is offset by continued conversion of patients to Neulasta, a longer-acting version of the drug. The company recently said that Neupogen biosimilars had captured just 4% of the international market as of the end of June.
