FDA Approves Biosimilar to Neulasta for the Prevention of Infection During Cancer Treatment

The US Food and Drug Administration (FDA) announced today that it 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 biosimilar 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, is quoted in the news release on the approval as saying, “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.”

Mylan and Biocon previously received a Complete Response Letter (CRL) for the pegfilgrastim biosimilar. At the time, Biocon indicated 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 (EMA) following a French regulatory inspection which 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.

According to the FDA, "The most common side effects of pegfilgrastim-jmdb are bone pain and pain in extremities. Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products should not take pegfilgrastim-jmdb. Serious side effects from treatment with pegfilgrastim-jmdb include rupture of the spleen, acute respiratory distress syndrome, serious allergic reactions including anaphylaxis, acute inflammation of the kidney (glomerulonephritis), an abnormally high level of white blood cells (leukocytosis), capillary leak syndrome and the potential for tumor growth. Fatal sickle cell crises have occurred."

An earlier version of this article was published on The Center for Biosimilars.