Now that the EMA has accepted the filing for the two products, an inspection will be due and Biocon has said it is ready for it. The bigger news was waiting post-market, when the US Food and Drug Administration said it has approved Mylan’s biosimilar product trastuzumab for launch. All decks are cleared for the US launch for trastuzumab, according to a Biocon spokesperson. A 1 December Reuters report quoted a Barclays analyst saying a launch was not expected before 2019, but that this approval adds credibility to Mylan’s biosimilar effort. These credentials not only matter for valuations but also for when Biocon may negotiate partnerships for its other under-development products.

Source: Mint December 04, 2017 03:33 UTC