FDA Accepts BLA for Sandoz’s Pegfilgrastim BiosimilarBy
The US Food and Drug Administration (FDA) has accepted the biologics license application of Sandoz, a Novartis company under the 351 (k) pathway for its proposed biosimilar to Amgen’s US-licensed Neulasta (pegfilgrastim), recombinant human granulocyte colony-stimulating factor (G-CSF), marking the company’s third biosimilar filed in the US. The abbreviated pathway under section 351(k) of the Public Health Service was established by the Biologics Price Competition and Innovation Act of 2009, enacted on March 23, 2010, as part of the Patient Protection and Affordable Care Act, to provide a regulatory pathway in the US for biosimilars.
Sandoz is seeking approval for the same indication as the reference product. Pegfilgrastim is a prescription medicine used to help reduce the chance of infection due to a low white blood cell count, in patients with cancer (non-myeloid) who receive chemotherapy that can cause fever and a low blood cell count (febrile neutropenia).In the US, the incidence of febrile neutropenia is estimated to be more than 60,000 a year, accounting for nearly eight cases per 1,000 cancer patients. Approximately 1.6 million people per year in the US develop non-myeloid cancer.
Sandoz believes that the totality of evidence in its submission, including three pivotal clinical trials , one pharmacokinetic and pharmacodynamic study in healthy volunteers and two comparative efficacy and safety studies in breast cancer patients, will demonstrate that the proposed biosimilar is highly similar to the reference product and therefore justifies use of biosimilar pegfilgrastim in the reference product’s indication.
Earlier this year, Sandoz received FDA approval for the first biosimilar in the US, Zarxio (filgrastim-sndz), a biosimilar to reference product, Neupogen, marketed by Amgen, which was originally licensed in 1991. Sandoz launched the product in the US in September 2015. The company also recently had its regulatory submission for proposed biosimilar etanercept accepted by the FDA. Etanercept is the active ingredient in Amgen’s Enbrel. Sandoz plans to make 10 planned regulatory filings over the next three years.