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.
The FDA has approved Pfizer’s Retacrit, a biosimilar alternative to Amgen’s Epogen and J&J’s Procrit, which the company will price at a "significant discount."
The US FDA has issued complete response letters (CRL) for the Rituxan and Herceptin biosimilar candidates after Celltrion’s facility received a warning in Janaury.
Mundipharma says it is not concerned at arriving second to market with a trastuzumab biosimilar after inking a deal to commercialise Celltrion’s Herzuma in seven European countries.
