Shots:
- Teva & Samsung Bioepis have launched Epysqli, a biosimilar version of Soliris (eculizumab) in the US to treat paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS) & generalized myasthenia gravis(gMG) in AchR antibody-positive adults
- Epysqli was approved by the US FDA in Jul 2024 for PNH & aHUS, with a label expansion to gMG in Nov 2024 & was also granted interchangeability designation by the FDA
- In Jan 2025, Samsung Bioepis & Teva have entered into a collaboration to commercialize Epysqli in the US market, with Samsung handling development, manufacturing, & supply, whereas Teva would handle commercialization
Ref: Teva | Image: Teva & Samsung Bioepis
Related News:- Teva Pharmaceuticals Reports the US FDA’s sBLA Acceptance of Ajovy (Fremanezumab) for Pediatric Episodic Migraine Prevention
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