Fylnetra Launches in the United States

Amneal Pharmaceuticals has announced the launch of its pegfilgrastim biosimilar, Fylnetra (pegfilgrastim-pbbk), for the treatment and prevention of febrile neutropenia, making it the sixth biosimilar referencing Neulasta to enter the US market.

The biosimilar is being offered in a prefilled single-dose syringe and was developed in collaboration with Kashiv Biosciences. It was approved in May 2022. The news comes after the launch of Eli Lilly and Company’s interchangeable insulin glargine biosimilar Rezvoglar (insulin glargine-aglr) in April 2023.

Pegfilgrastim is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. Febrile neutropenia is a common complication associated with chemotherapy, where patients have a low number of neutrophils to fight infections.

“Fylnetra marks our third US biosimilar launch since late last year. We are excited to be contributing to this next wave of affordable medicines, and we are well positioned to drive access across patients, providers, and payors. Although it’s only the early innings for the growing biosimilars market, we are focused on becoming a key player over the long term. These first 3 launches are just the start for Amneal in biosimilars,” said Harsher Singh, senior vice president of Amneal’s Biosciences division.

In addition to Fylnetra, the FDA has approved Nyvepria (pegfilgrastim-apgf; June 2020), Ziextenzo (pegfilgrastim-bmez; November 2019), Udenyca (pegfilgrastim-cbqv; November 2018), Stimufend (pegfilgrastim-fpgk; September 2022), and Fulphila (pegfilgrastim-jmdb; June 2018). The launch of Fylnetra also comes after Stimufend launched in February 2023 and the FDA approved an autoinjector version of Udenyca in March 2023.

“We are pleased to launch the Fylnetra biosimilar. This launch builds on our successful partnership with Amneal and the good uptake we are seeing of the Releuko biosimilar, which was launched in the fourth quarter of 2022. Kashiv is one of a few companies based in the United States to manufacture and launch multiple biosimilars. Kashiv aims to continue bringing high-quality biosimilars to the global markets over the coming years,” said Chandramauli Rawal, MD, chief operating officer at Kashiv.