US FDA rejects another Herceptin biosimilar, Amgen issued CRL
The US FDA has issued a complete response letter to Amgen for its biosimilar version of Roche’s Herceptin, marking the agency’s third trastuzumab candidate rejection this year.
Archives for June 5, 2018
Mylan and Biocon win Neulasta race with US FDA-approved biosimilar
The US FDA has approved Mylan and Biocon’s Fulphila, the first biosimilar version of Amgen’s Neulasta to receive regulatory authorisation.