First Pegfilgrastim Biosimilar Receives Approval

The U.S. Food and Drug Administration (FDA) has approved pegfilgrastim-jmdb, a biosimilar version of pegfilgrastim, which is indicated to decrease the duration of neutropenia in patients receiving chemotherapy.

A product is considered a biosimilar if it is similar but not identical to a biologic already approved by the FDA. The FDA’s approval of pegfilgrastim-jmdb is based on its review of structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data.

The agency also noted that pegfilgrastimjmdb is approved as a biosimilar, not as an interchangeable product.

The most common AEs associated with either pegfilgrastim or its biosimilar are bone pain and pain in the extremities. Other AEs include spleen rupture, acute respiratory distress syndrome, serious allergic reactions including anaphylaxis, glomerulonephritis, leukocytosis, capillary leak syndrome, tumor growth, and fatal sickle-cell crises.

In a press release announcing the approval, FDA Commissioner Scott Gottlieb, MD, reiterated the agency’s commitment to biosimilar approval and his desire for new policies to promote biosimilar development: “We’ll 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.”

Sources: Reuters, June 4, 2018; FDA news release, June 4, 2018; Mylan press release, June 6, 2018.