- The Food and Drug Administration has declined to approve Pfizer Inc.'s proposed biosimilar version of Roche AG's breast cancer drug Herceptin, issuing a Complete Response Letter that asks for further technical information.
- Pfizer said in an April 23 statement the FDA's request was not related to either safety or clinical data for the copycat biologic, but did not offer additional details on how long the CRL would take to address.
- While Pfizer will likely resubmit its biosimilar in the future, the FDA's decision preserves Mylan N.V.'s edge as the only drugmaker to win approval of a Herceptin copy in the U.S. Due to ongoing legal hurdles, however, it's not clear when Mylan will be able to actually sell the knockoff drug.
Pfizer has had mixed success with biosimilar drug development, previously winning approval in the U.S. for two versions of the anti-inflammatory treatment Remicade (infliximab) but failing to secure an OK for a copy of Amgen Inc.'s Epogen (epoetin alfa).
Commercially, the pharma's efforts to sell the first of its Remicade biosimilars have been hamstrung by rival Johnson & Johnson's defensive contracting with payers for the branded version of the drug. In a lawsuit filed last September, Pfizer alleges J&J has shut out competitors by striking exclusive deals with payers.
In Europe, however, the story is a bit different, with brisker sales of Pfizer's copy. Last year, Pfizer reported sales of Inflectra (infliximab-dyyb) totaled $118 million in the U.S. and $301 million in Europe, where the drug is sold as Remsima.
Winning approval of biosimilar Herceptin (trastuzumab) would have represented Pfizer's first step in cancer biosimilars. While the CRL from the FDA doesn't appear particularly damning, the rejection will likely set back the pharma's plans for some time.
The decision also comes quickly on the heels of a CRL issued to Celltrion Inc. and Teva Pharmaceuticals Industries Ltd. for a biosimilar version of Herceptin and another Remicade copy.
Meanwhile, Roche faces numerous competitive challenges to its trio of top-selling biologics, which include Herceptin as well as Rituxan (rituximab) and Avastin (bevacizumab).
Despite the threat to its bottom line, the Swiss drugmaker has remained confident it will be able to compete while its newer drugs come on.
Shares in Pfizer were little moved Monday, while Roche's stock traded roughly 1% higher on Swiss markets.