Amneal Pharmaceuticals’s Releuko (biosimilar, filgrastim) Receives the US FDA’s Approval of BLA for the Treatment of Neutropenia
- The US FDA has approved the BLA for filgrastim-ayow, a biosimilar referencing Neupogen to treat neutropenia. Releuko has been developed in collaboration with Kashiv & will be marketed under the name Releuko
- The company is expected to launch Releuko in Q3’22 along with a full patient support program & is planning to launch pegfilgrastim biosimilar referencing Neulasta and a bevacizumab biosimilar referencing Avastin in 2022
- Releuko is supplied in single-dose vials & prefilled syringes containing 300/480mcg of filgrastim-ayow in a preservative-free solution
Ref: Amneal | Image: Amneal
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