The EMA’s human medicines committee has recommended approval of a fixed-dose combination of Roche’s breast cancer drugs Herceptin and Perjeta – part of the company’s defense against Hercept
Amgen has scored yet another home run in the US courts, this time seeing off a legal challenge from Genentech, which was trying to block it from launching two cut-price cancer biosimilars.
As biosimilar competition to Herceptin ramps up, Roche is looking to bolster its position in HER2-positive breast cancer with a new indication for Kadcyla.
European Commission (EC) has approved Pfizer’s Trazimera, for breast and gastric cancer treatment, marking it as pharma’s first oncology biosimilar to receive approval in the EU.