FDA Approves Third Pegfilgrastim Biosimilar for Neutropenia

US FDA

FDA has approved the biologics license application for pegfilgrastim-pbbk (Fylnetra), a biosimilar referencing Neulasta for the treatment of neutropenia, according to a press release from the developer of the agent, Amneal Pharmaceuticals.

The product, developed in collaboration with Kashiv Biosciences, LLC of Chicago, Illinois, represents the third biosimilar approval for Amneal in oncology this year. In addition to Fylnetra, the FDA 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 over the second half of 2022, along with a full patient support program.

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

Fylnetra is a leukocyte growth factor designed to decrease the onset of infection in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs that are associated with a clinically significant rate of febrile neutropenia. Notably, the product is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Regarding safety, the agent is contraindicated in patients with a history of severe allergic reactions to human granulocyte colony-stimulating factors (G-CSF) including filgrastim products or pegfilgrastim products. The most common adverse effects with at least a 5% difference in incidence vs placebo were bone pain and pain in extremity.

In addition, the company listed several warnings and precautions regarding the agent’s use 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. Further instances of capillary leak syndrome, myelodysplastic syndrome and acute myeloid leukemia, aortitis, and increased hematopoietic activity of the bone marrow in response to growth factor therapy associated with temporary positive bone imaging changes have also been reported following G-CSF administration.

Moreover, the company stated 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,” Chandramauli Rawal, MBBS, chief operating officer for Kashiv said in a news 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. I would like to extend a humble thank you to our highly talented team, without whom this would not have been possible.”

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://bit.ly/3N3AgPv