Posted by Michael Wonder on 19 Jul 2016
FDA knocks back Novartis copy of Amgen's drug Neulasta
19 July 2016 - U.S. regulators have declined to approve Novartis' so-called biosimilar copy of Amgen's Neulasta drug that fights infections in cancer patients, the Swiss drug maker said on Tuesday.
Vasant Narasimhan, head of development at Novartis Pharmaceuticals, said the FDA had issued a complete response letter for the product at the end of June, without giving further details.
