FDA Approves Fifth Pegfilgrastim Biosimilar

The FDA has approved pegfilgrastim-pbbk (Fylnetra), a biosimilar product referencing Neulasta (pegfilgrastim).¹

This represents the fifth pegfilgrastim biosimilar approved by the FDA after pegfilgrastim-apgf (Nyvepria), pegfilgrastim-bmez (Ziextenzo), pegfilgrastim-cbqv (Udenyca), and pegfilgrastim-jmdb (Fulphila).

Pegfilgrastim-pbbk is a leukocyte growth factor intended to reduce the frequency of febrile neutropenia in patients with non-myeloid malignancies who are receiving myelosuppressive chemotherapy.1,2 Treatment with pegfilgrastim-pbbk is to be administered at 6 mg subcutaneously once during each chemotherapy cycle.

Common adverse events reported with the biosimilar include bone pain and pain in the extremity. In clinical trials, bone pain was reported in 31% of 467 patients who received pegfilgrastim and pain in extremity was reported in 9%. Leukocytosis was reported in fewer than 1% of 932 pegfilgrastim-treated patients.

The label for pegfilgrastim-pbbk includes warnings for fatal splenic rupture, acute respiratory distress syndrome, serious allergic reactions such as anaphylaxis, fatal sickle cell crises, glomerulonephritis, thrombocytopenia, and myelodysplastic syndrome or acute myeloid leukemia. Careful monitoring for signs of these serious adverse events is recommended. Treatment with pegfilgrastim-pbbk should be discontinued in the case of acute respiratory distress syndrome, serious allergic reactions, or sickle cell crisis.

Additionally, the developer (Amneal Pharmaceuticals in collaboration with Kashiv Biosciences) noted that aortitis and increased hematopoietic activity of the bone marrow are additional possible occurrences with pegfilgrastim treatment deserving of caution.

Pegfilgrastim-pbbk is expected to be launched in the second half of the year with a full patient support program.

“This is our third U.S. biosimilar approval this year and we are very enthusiastic about our future in the fast growing…US biosimilars market,” co-chief executive officers of Amneal Pharmaceuticals, Inc., Chirag and Chintu Patel, said in a press release. “Biosimilars represent the next wave of affordable medicines and are closely aligned with our mission to provide high quality, affordable medicines to as many patients as possible.”

_References:

_{1. Amneal Achieves Third U.S. Biosimilar Approval with FYLNETRA™ (pegfilgrastim-pbbk). News release. Amneal Pharamceuticals, Inc. May 27, 2022. Accessed May 31, 2022. https://bit.ly/3wXsAaW}

_{2. Fylnetra. Prescribing information. Amneal Pharmaceuticals, 2022. https://bit.ly/3lWUcYw}