Pfizer indicated that Nivestym will be priced at a wholesale acquisition cost (WAC) of $350.40 per 480-mcg prefilled syringe, a WAC that is 30.3% lower than that of the reference Neupogen.
A representative from Pfizer told The Center for Biosimilars® in an email that Nivestym, an FDA-approved biosimilar filgrastim (referencing Neupogen), became commercially available in the United States on October 1. Pfizer began shipping the biosimilar to wholesalers on September 24.
Pfizer indicated that Nivestym will be priced at a wholesale acquisition cost (WAC) of $350.40 per 480-mcg prefilled syringe, a WAC that is 30.3% lower than that of the reference Neupogen, 20.3% lower than that of Zarxio (Sandoz’s biosimilar filgrastim), and 14.1% lower than that of Granix (or tbo-filgrastim, Teva’s follow-on filgrastim product cleared by the FDA prior to the establishment of a biosimilar approval pathway).
Nivestym, like its reference, is a granulocyte-colony stimulating factor that is approved to treat neutropenia in patients who are undergoing myelosuppressive chemotherapy or who have other types of severe neutropenia, and to mobilize autologous hematopoietic progenitor cells into peripheral blood for leukapheresis.
While the United States has 12 approved biosimilar products, Nivestym is only the fifth such product to launch; some biosimilar products, such as Sandoz’s etanercept, Erelzi, or Amgen’s adalimumab, Amjevita, have yet to launch despite having been approved in 2016, due in part to a complex patent landscape and ongoing legal challenges.
However, if recent trends are an indication of the future of the marketplace, patients may be able to access biosimilars—and health systems may be able to reap cost savings—sooner. It took Pfizer mere months to launch Nivestym, which was approved in July 2018. Similarly, Mylan and Biocon’s pegfilgrastim biosimilar, Fulphila, was approved in June 2018 and launched just 1 month later in July.