Mylan has filed for FDA approval of its biosimilar copy of Roche’s Herceptin, teeing it up to start chipping away at a cornerstone of the Big Pharma's business.
A month after Mylan and Biocon saw the EMA accept their marketing application for a copycat version of Roche’s major blockbuster cancer med Herceptin (trastuzumab)--the first to do so--Samsung Bioepis says it too has now notched that regulatory milestone as the companies race to market.
Fresh off a positive FDA panel earlier this month for what could be its first approved biosimilar for Humira, Amgen--and partner Allergan--have reported positive top-line Phase III data for its Herceptin biosimilar.
