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FDA accepts first application for biosimilar filgrastim
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Sandoz Inc. recently announced that the 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 company filed for the approval of filgrastim (Zarzio), a biosimilar of the reference product Neupogen (Amgen), which is indicated to decrease the incidence of infection – manifested by febrile neutropenia – in patients with non-myeloid malignancies who are also receiving myelosuppressive anti-cancer drugs.
Under the BPCIA, a biosimilar biologic is defined as highly similar to the reference product with no clinically meaningful differences between the biological product and the reference product in terms of safety, purity and potency.
“This filing acceptance represents a significant step toward making high-quality biologics more accessible in the US and we applaud FDA for its progress in making this a reality,” Mark McCamish, MD, PhD, head of global biopharmaceutical & oncology injectables development at Sandoz, said in a press release. “As they've done in Europe and other highly-regulated markets around the world, biosimilars are poised to increase US patient access to affordable, high-quality biologics, while reducing the financial burden on payers and the overall healthcare system.”