Shots:
- The US FDA has approved Starjemza (BAT2206), a biosimilar version of Stelara (ustekinumab) for all indications of the reference product
- Approval was based on comprehensive analytical, non-clinical, & clinical data incl. extensive analytical characterization, P-I trial in healthy subjects & P-III trial in mod. to sev. plaque PsO pts, showing similar efficacy, safety, PK & immunogenicity of Starjemza vs US & EU Stelara
- In Aug 2021, Bio-Thera & Hikma entered into a license & commercialization agreement, with Bio-Thera responsible for the development & manufacturing of Starjemza, & Hikma handling its commercialization in the US
Ref: Prnewswire | Image: Bio-Thera & Hikma| Press Release
Related News:- Bio-Thera Collaborates with Intas Pharmaceuticals for the Commercialization of BAT2506 (Biosimilar, Simponi) Across the US
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