FDA Approves First Pegfilgrastim Biosimilar, Fulphila

The FDA has approved Mylan and Biocon’s pegfilgrastim biosimilar, pegfilgrastim-jmdb. The product, the first biosimilar pegfilgrastim approved in the United States, will be sold under the brand name Fulphila.

The drug is approved to decrease the incidence of infection as manifested by febrile neutropenia in patients receiving myelosuppressive chemotherapy, but, like the reference Neulasta, is not approved for mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

FDA Commissioner Scott Gottlieb, MD, hailed the approval, saying in a statement, “Bringing new biosimilars to patients is a top priority for the FDA, and a key part of our efforts to help promote competition that can reduce drug costs and promote access.” He added that the agency will “…continue to prioritize reviews of these products to help ensure that biosimilar medications are brought to the market efficiently and through a process that makes certain that these new medicines meet the FDA’s rigorous standard for approval.”

The approval comes as welcome news for the partnership; Mylan and Biocon previously received a Complete Response Letter (CRL) for the pegfilgrastim biosimilar. Biocon indicated at the time that the CRL related to “data from facility requalification activities” after it made modifications to its manufacturing plant, and that the CRL did not raise questions concerning the drug’s biosimilarity, pharmacokinetic or pharmacodynamic data, clinical data, or immunogenicity.

The company also withdrew its application for the product from the European Medicines Agency following a French regulatory inspection noted 35 problems with Biocon’s manufacturing facility. It later resubmitted the application to the EMA, where it awaits a regulatory decision.

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.