U.S. Drug Regulator Delays Decision On Biocon, Mylan’s Breast Cancer Biosimilar
U.S. FDA delays decision on Biocon, Mylan’s Trastuzumab biosimilar.
The U.S. drug regulator has given Mylan Pharmaceuticals Pvt. Ltd. and Biocon Ltd. a three-month extension to get necessary approvals for selling a nearly identical copy of a breast cancer drug by Swiss drugmaker Roche AG.
Mylan was notified by the U.S. Food and Drug Administrator that they will extend the target action date for the Trastuzumab drug application to December 3, 2017, according to a stock exchange filing by its Indian partner Biocon Ltd.
The extension comes after the European drug regulator asked Biocon to withdraw applications for Trastuzumab and Pegfilgrastim until the Bengaluru-headquartered company fulfilled procedural requirement linked to re-inspection of its manufacturing facility in Bengaluru. Earlier this month, the U.S. FDA had also found ten lapses in quality at the Bengaluru plant, pointing towards asceptic practices.
The Trastuzumab drug, used to treat breast and stomach cancer, is marketed by the Roche Group under the name Herceptin. Biocon's CANMAB and Mylan Hertraz have claimed biosimilarity to Trastuzumab, meaning that their drug is highly similar to an already approved biological product. Their claim was upheld by the Delhi High Court in March. It had also received unanimous backing from an U.S. FDA panel in July.
Roche's patent for Herceptin in Europe had expired in 2014, but the drug continues to be a best-seller generating nearly $7 billion in sales last year.
A Biocon spokesperson said that the extension was in order to review some "clarificatory information" and would have no impact on the anticipated timetable for the commercialisation of the drug in U.S. The decision by U.S. FDA was expected by September 3.
Morgan Stanley, in an analysis on August 23, had said one possible scenario while deciding the target action date for the Trastuzumab could be a delay of two to four months. The brokerage had pegged the target price for Biocon at Rs 305-310 per share in the event of such a delay.
Shares of Biocon Ltd. had closed 0.8 percent higher, ahead of the announcement, tracking the country's benchmark BSE Sensex that gained 0.8 percent.