Drug maker Mylan, which in June received FDA approval for its biosimilar pegfilgrastim, Fulphila, confirmed in an email to The Center for Biosimilars® that it has launched the biosimilar in the United States marketplace. Fulphila is the fourth biosimilar—and the first pegfilgrastim biosimilar—to become available to US patients.
Drug maker Mylan, which in June received FDA approval for its biosimilar pegfilgrastim, Fulphila, confirmed in an email to The Center for Biosimilars® that it has launched the biosimilar in the United States marketplace. Fulphila is the fourth biosimilar—and the first pegfilgrastim biosimilar—to become available to US patients.
The biosimilar, like its reference, Amgen’s Neulasta, is approved to decrease the incidence of infection as manifested by febrile neutropenia in patients receiving myelosuppressive chemotherapy.
Fulphila launched at a wholesale acquisition cost (WAC) of $4175 per syringe, a price that reflects both a 33% discount to the WAC of Amgen’s innovator product and a deeper discount to a reference drug than any other first biosimilar launched in the United States.
While Mylan has not yet made a corporate statement about the launch of the drug, the FDA’s National Drug Code Directory indicates that marketing for Fulphila began on July 9. Litigation over patents covering the reference Neulasta is ongoing, despite Mylan's choice to launch the drug; on July 23, Amgen and Mylan filed a joint motion for a status conference to determine whether the discovery process should proceed in a case that has been ongoing since September 2017.
The biosimilar was developed in conjunction with Indian biosimilar developer Biocon, which noted in reporting its quarterly financial results that its regulatory submissions for Fulphila in the European Union, Australia, and Canada are also “progressing well.” The Mylan—Biocon partnership currently has 1 additional biosimilar product approved by the FDA: Ogivri, a trastuzumab biosimilar referencing Herceptin. The drug has not yet been launched in the United States.
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.
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.
Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar
April 29th 2024The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.