FDA Accepts BLA for Sandoz’s Biosimilar of Filgrastim
Sandoz, a Novartis Group company, reports that the US Food and Drug Administration (FDA) has accepted its biologics license application for filgrastim, which was filed under the new biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009.
The reference product, Amgen’s Neupogen, is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever.
Under the brand name Zarzio, Sandoz’s biosimilar filgrastim is marketed in more than 40 countries outside the US. Sandoz estimates that the company has more than a 50% share of the biosimilars markets in Canada, Europe, Japan, and Australia. Sandoz currently markets three biosimilars outside the US: Omnitrope (somatropin [rDNA origin] injection, a biosimilar version of human growth hormone; Binocrit (epoetin alfa), and Zarzio.
Sandoz also has other biosimilar molecules in Phase III clinical trials/filing preparation: adalimumab for treating chronic stable plaque psoriasis; etanercept for treating chronic stable plaque psoriasis; rituximab for treating two separate indications, follicular lymphoma and rheumatoid arthritis; pegfilgrastim for treating chemotherapy-induced febrile neutropenia; and epoetin-alfa for treating anemia due to chronic kidney disease (for the US; already approved in the EU).