FDA Issues Complete Response Letter for Rituximab Biosimilar

May 3, 2018 – The FDA has issued a complete response letter (CRL) to Sandoz (Novartis) regarding a biologics license application (BLA) for the rituximab biosimilar GP2013. The CRL indicates that the FDA has completed its review and the BLA is not ready for approval. Sandoz did not provide further details in its statement on the CRL. “Sandoz stands behind the robust body of evidence included in the regulatory submission and is currently evaluating the content of … (leggi tutto)