Therapy Areas: Central Nervous System
Amneal Enters US Biosimilars Market with Approval of Releuko
2 March 2022 - - The US Food and Drug Administration approval of the Biologics License Application for filgrastim-ayow, a biosimilar referencing Neupogen, US-based Amneal Pharmaceuticals, Inc. (NYSE: AMRX) said.

The product will be marketed under the proprietary name Releuko.

Releuko was developed in collaboration with Kashiv Biosciences, LLC located in Chicago, Illinois. It 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.

Amneal said it expects to launch Releuko in 3Q22, along with a full patient support program.

The company is planning for a pegfilgrastim biosimilar referencing Neulasta and a bevacizumab biosimilar referencing Avastin to launch in 2022. Both are being reviewed by the FDA.

According to Iqvia, US annual sales for filgrastim for the 12 months ended December 2021 were USD 407m, of which USD 275m represents biosimilar sales.

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, New Jersey, is an essential medicines company.

The company has a diverse portfolio of approximately 250 products in its Generics segment and is expanding across a broad range of complex products and therapeutic areas, including injectables and biosimilars.

In its Specialty segment, Amneal has a growing portfolio of branded pharmaceutical products focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs.

Through its AvKARE segment, the company is a distributor of pharmaceuticals and other products for the US federal government, retail, and institutional markets.
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