Mylan Confirms That It Has Launched Fulphila in the United States

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.