Sandoz Resubmits Application for Pegfilgrastim Biosimilar

April 5, 2019 – A biologics license application has been resubmitted to the FDA for the pegfilgrastim biosimilar LA-EP2006 to decrease the incidence of infection from febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer therapy. The resubmission addresses a complete response letter (CRL) issued by the FDA in June 2016, according to Sandoz, the manufacturer of the agent. Pegfilgrastim is a long-acting … (leggi tutto)