Third Pegfilgrastim Biosimilar Gains FDA Approval for Neutropenia

The FDA has granted approval to a biologics license application for pegfilgrastim-pbbk (Fylnetra), a biosimilar of Neulasta, for the treatment of neutropenia, according to manufacturer Amneal Pharmaceuticals.

Pegfilgrastim-pbbk is the third oncology biosimilar developed by Amneal to gain FDA approval this year. The FDA also approved filgrastim-ayow (Releuko), a filgrastim biosimilar referencing Neupogen, and bevacizumab-maly (Alymsys), a bevacizumab biosimilar referencing Avastin.

Amneal plans to launch all 3 products during the second half of 2022, accompanied by a full patient support program, according to a company press release.

“We are very enthusiastic about our future in the fast growing $28 billion US biosimilars market,” said Chirag Patel and Chintu Patel, co-chief executive officers of Amneal Pharmaceuticals, in the 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.”

Pegfilgrastim-pbbk is a leukocyte growth factor developed to reduce the onset of infection in patients with non-myeloid malignancies administered myelosuppressive anticancer medications associated with a clinically significant rate of febrile neutropenia. Pegfilgrastim-pbbk is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation, according to Amneal.

Pegfilgrastim-pbbk is contraindicated in patients with a history of severe allergic reactions to human granulocyte colony-stimulating factors (G-CSF), including filgrastim or pegfilgrastim products. The most frequently observed adverse effects associated with pegfilgrastim-pbbk with at least a 5% difference in incidence compared with placebo were bone pain and pain in the extremity, according to Amneal.

Further, Amneal listed several warnings and precautions with the use of pegfilgrastim-pbbk, including fatal splenic rupture, acute respiratory distress syndrome, fatal sickle cell crises, severe allergic reactions, including anaphylaxis, kidney injury, decreased platelet count, and increased white blood cell count. Capillary leak syndrome, myelodysplastic syndrome and acute myeloid leukemia, aortitis, and elevated hematopoietic activity of the bone marrow in response to growth factor therapy associated with temporary positive bone imaging changes were also reported following G-CSF administration.

Amneal noted that physicians should be aware of the potential for pegfilgrastim products to act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia. Pegfilgrastim products are not approved for these diseases.

“Building on our successful partnership with the recent approval of our first biosimilar, Releuko, we are pleased to receive approval for our second biosimilar,” said Chandramauli Rawal, MBBS, chief operating officer for Kashiv, in a press release. “Kashiv is one of a few domestic companies to manufacture and launch multiple biosimilars in the United States. Kashiv aims to continue bringing high quality biosimilars to the global markets over the coming years..”

Reference

1. Amneal achieves third U.S. biosimilar approval with FYLNETRA™ (pegfilgrastim-pbbk). News release. Amneal Pharmaceuticals. May 27, 2022. Accessed May 31, 2022. https://investors.amneal.com/news/press-releases/press-release-details/2022/Amneal-Achieves-Third-U.S.-Biosimilar-Approval-with-FYLNETRA-pegfilgrastim-pbbk/default.aspx