The FDA has approved Pfizer's filgrastim-aafi, a filgrastim biosimilar to Amgen's Neupogen. The product, the second filgrastim biosimilar approved in the United States, will be sold under the brand name Nivestym.
The FDA on Friday approved Pfizer's filgrastim-aafi, a filgrastim biosimilar to Amgen's Neupogen. The product, the second filgrastim biosimilar approved in the United States, will be sold under the brand name Nivestym.
“The FDA approval of Nivestym marks an important step in helping expand access to critical treatment options for patients with neutropenia, many of whom have cancer and can be hospitalized for potentially life-threatening side effects stemming from chemotherapy,” said Berk Gurdogan, US institutions president for Pfizer Essential Health, in a statement made to The Center for Biosimilars®. “We believe biosimilars, like Nivestym, are essential in helping to address evolving healthcare needs and may provide more affordable medicines to patients.”
The drug is approved for the same indications as the reference product, including decreasing the incidence of infection due to neutropenia. Specifically, the drug has been approved to treat side effects from cancer treatment for patients:
Nivestym will prospectively follow Sandoz’s Zarxio to the United Sates market for filgrastim. Zarxio was not only the first filgrastim to reach American patients (prior to implementation of the Biologics Price Competition and Innovation Act—BPCIA—pathway, tbo-filgrastim was approved as a follow-on drug), but also the first biosimilar approved in the United States under the BPCIA pathway.
Since its introduction, the supportive care product, which is a less complex molecule than an anticancer molecule such as trastuzumab or bevacizumab, has gained general acceptance among providers and patients, and it has allowed for cost savings in clinical practice.
Pfizer has not yet announced how it will price its biosimilar filgrastim to compete with tbo-filgrastim, Zarxio, or the reference product, nor has it supplied a prospective launch date for the drug.
Nivestym is the third biosimilar approved in 2018; the most recent biosimilar to receive FDA approval was pegfilgrastim-jmdb in June 2018. The product was developed in a joint partnership by Mylan and Biocon which will be sold under the brand name Fulphila. Prior to Fulphila, the FDA approved Pfizer’s biosimilar epoetin alfa, referencing Epogen.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032
April 11th 2024The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.