Amgen has filed for approval from the European Union’s European Medicines Agency (EMA) for ABP 980, its biosimilar of the breast cancer treatment trastuzumab (Roche’s Herceptin), according to a presentation by Amgen’s executive vice president and chief financial officer David Meline at the Cowen and Company 37th Annual Health Care Conference on March 8, 2017. The report also suggests that Amgen is likely to file for its trastuzumab biosimilar’s approval in the United States, but the timing for that event is uncertain.
A biosimilar for trastuzumab has not yet been approved by the EMA or the FDA. The EMA’s website indicates that the agency is currently assessing 3 trastuzumab biosimilars, with Mylan/Biocon’s trastuzumab being the first under consideration for approval in 2017. Asia is already marketing a trastuzumab biosimilar and a recent court decision in New Delhi, India, allowed the marketing of Mylan/Biocon’s biosimilar of trastuzumab in that country.
Launch of a biosimilar of trastuzumab in Europe is expected to occur before a similar approval in the United States, but indications are growing stronger that Mylan’s trastuzumab biosimilar may be approved in September 2017 based on the recent announcement that Mylan entered a global settlement with Genentech and Hoffman-La Roche on a patent for trastuzumab. The agreement will provide Mylan with global licenses for its trastuzumab biosimilar, which allows Mylan and partner Biocon to commercialize the drug around the world with the exception of Japan, Brazil, and Mexico. The agreement also ensures that the US market will see the first biosimilar to trastuzumab, once Mylan’s biologics license application—filed in collaboration with Biocon—is approved by the FDA.
The Biosimilar User Fee Act for trastuzumab is September 3, 2017.