FDA Approves 4th Biosimilar to Neulasta – Fylnetra

The FDA recently approved the fourth pegfilgrastim biosimilar referencing Neulasta, Fylnetra (pegfilgrastim-pbbk) from Amneal Pharmaceuticals. Fylnetra is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Can the market support four biosimilars with the same indication? Yes….. in time.
According to IQVIA, U.S. annual sales for pegfilgrastim for the 12 months ended March 2022 were $3.1 billion, $1.0 billion of which represented biosimilar sales. There is certainly a lot of room to gain share even in an already crowded category.

Amneal did not indicate a price point for the launch of Fylnetra. The GoodRx price for each of the biosimilars already on the market have broken the $4000 threshold. One might expect that additional competition would put further downward pressure on launch price or discounting off WAC. The cost for brand Neulasta is over $6000, positioning the current biosimilars at a 30+% discount to the brand.


Amneal Achieves Third U.S. Biosimilar Approval with Fylnetra (pegfilgrastim-pbbk)

May 27, 2022 — Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (“FDA”) has approved the Company’s Biologics License Application (“BLA”) for pegfilgrastim-pbbk, a biosimilar referencing Neulasta. The product will be marketed under the proprietary name Fylnetra.

Fylnetra was developed in collaboration with Kashiv Biosciences, LLC, located in Chicago, Illinois. It is used to treat neutropenia which is commonly experienced by patients undergoing chemotherapy.

This marks the third biosimilar approval Amneal received this year for products used in oncology, the second-largest biosimilar category in the U.S. Earlier this year, Amneal received approval of Releuko (filgrastim-ayow), a filgrastim biosimilar referencing Neupogen, and Alymsys (bevacizumab-maly), a bevacizumab biosimilar referencing Avastin. Amneal expects to launch these three products over the second half of 2022, along with a full patient support program.

“This is our third U.S. biosimilar approval this year and we are very enthusiastic about our future in the fast growing $28 billion U.S. 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,” said Chirag and Chintu Patel, Co-Chief Executive Officers.

“Building on our successful partnership with the recent approval of our first biosimilar, Releuko, 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. I would like to extend a humble thank you to our highly talented team, without whom this would not have been possible,” said Dr. Chandramauli Rawal, Chief Operating Officer for Kashiv.

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