The US Food and Drug Administration (FDA) has approved Pfizer’s Nivestym; a second biosimilar of Amgen’s Neupogen (filgrastim).
In March 2015, the FDA approved its first biosimilar: a version of Neupogen called Zarxio, marketed by Novartis subsidiary Sandoz.
Three years later and a second filgrastim biosimilar is close to being available after the FDA approved Pfizer’s product NIvestym.
A spokesperson from the Biopharma firm told BioProcess Insider Pfizer will be able to compete against both Amgen’s reference biologic and Sandoz’s Zarxio.
“The availability of biosimilars to the market will create competition and drive value,” we were told. “We believe uptake and utilization of Nivestym in the US will be dependent upon multiple factors, including confidence on the part of healthcare providers and patients that the biosimilar will perform as well as the reference product and other filgrastim biosimilars.”
The spokesperson added Pfizer’s pricing and commercialization strategy will also play a part in gaining a share of the figrastim market, though specifics are yet to have been revealed.
“Nivestym is expected to be available in the US at a significant discount to the current wholesale acquisition cost (WAC) of Neupogen.
“WAC is not inclusive of discounts to payers, providers, distributors and other purchasing organizations. By introducing biosimilars like NIVESTYM to the U.S. market, Pfizer hopes that patients and their healthcare providers will have improved access to a high-quality, potentially lower-cost treatment option.”
Nivestym becomes the twelfth biosimilar to be approved by the FDA: