Biosimilar Pegfilgrastim BLA Accepted by FDA for Neutropenia During Chemotherapy

A biologics license application for pegfilgrastim-pbbk was accepted by the FDA for use in patients experiencing neutropenia while receiving chemotherapy.

The FDA has accepted a biologics license application for a biosimilar referencing Neulasta, pegfilgrastim-pbbk (Flynetra), as a treatment for neutropenia in patients undergoing chemotherapy, according to a press release from Amneal.

Pegfilgrastim-pbbk was developed as a leukocyte growth factor to help decrease the incidence of infection from febrile neutropenia. This will help those with non-myeloid malignancies who have received myelosuppressive anti-cancer drugs that were shown to have a clinically significant incidence of febrile neutropenia.

Several other biosimilar applications have been accepted by the FDA, including filgrastim-ayow (Releuko), referencing Neupogen, and bevacizumab-maly (Alymsys), referencing bevacizumab (Avastin). It is anticipated that the 3 agents will be in use in the second half of the year with a full patient support program.

“Building on our successful partnership with the recent approval of our first biosimilar, [filgrastim-ayow], we are pleased to receive approval for our second biosimilar. 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,” Chandramauli Rawal, MD, chief operating officer for Kashiv.

The company has noted that this treatment should not be used for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. In terms of safety, this treatment is contraindicated for those with a history of serious allergic reactions to human granulocyte colony–stimulating factors (G-CSF), which include filgrastim and pegfilgrastim products.

It is also advised to check whether patients are pregnant, breastfeeding, have sickle cell disorder, kidney problems, or are receiving radiation therapy.

Common adverse effects associated with this treatment that occurred in 5% of patients or more included bone and extremity pain.

Several warnings and precautions have been detailed by the company and included fatal splenic rupture, acute respiratory distress syndrome, fatal sickle cell crises, and serious allergic reactions. Patients may also experience glomerulonephritis, thrombocytopenia, and capillary leak syndrome after G-CSF administration.

It is worth noting that pegfilgrastim products act as a growth factor for any tumor types for those with myeloid malignancies and myelodysplasia. Patients with breast or lung cancer should be monitored closely for signs and symptoms of acute myeloid leukemia or myelodysplastic syndrome. There have been reports of aortitis and increased hematopoietic activity of the bone marrow.

“This is our third United States biosimilar approval this year and we are very enthusiastic about our future.... 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 and Chintu Patel, co-chief executive officers at Amneal, concluded


Amneal achieves third U.S. biosimilar approval with Fylnetra (pegfilgrastim-pbbk). News Release. Amneal. May 27, 2022. Accessed June 1, 2022.