Amneal launches Fylnetra biosimilar

Amneal is introducing Fylnetra (pegfilgrastim-pbbk), a biosimilar of Neulasta, in a pre-filled single-dose syringe.

Fylnetra is used to treat neutropenia (low neutrophils which are a type of white blood cells that fight infection), which is commonly experienced by patients undergoing chemotherapy. This product was developed in collaboration with Kashiv Biosciences.

“Fylnetra marks our third U.S. 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 three launches are just the start for Amneal in biosimilars,” said Harsher Singh, senior vice president of Amneal Biosciences division.

[Read more: Amneal touts 26 generic new product launches in 2022]

“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, chief operating officer of Kashiv.

[Read more: Amneal debuts 2 generics]

Pegfilgrastim had a market value of $2.6 billion for the 12 months ended March 2023, of which $908 million represented biosimilar sales, Amneal said.