Shots:
- The US FDA has received a BLA for a biosimilar candidate to Novartis’ Xolair (omalizumab), developed by Kashiv BioSciences
- Additionally, Amneal expects to incur a $22.5M R&D milestone charge in Q3’25 instead of Q4 due to the earlier BLA filing & holds exclusive US commercialization rights for the product pending regulatory approval
- Xolair is a humanized mAb designed to block IgE binding to FcεRI on mast cells & basophils for the treatment of mod. to sev. persistent asthma (pts: ≥6yrs.), CRSwNP (≥18yrs.), food allergies (≥1yr.), & chronic spontaneous urticaria (≥12yrs.)
Ref: Amneal Pharmaceuticals | Image: Amneal Pharmaceuticals | Press Release
Related News:- Kashiv BioSciences and Amneal Pharmaceuticals Report Topline Results from the Study of ADL-018 (Biosimilar, Xolair) for CIU/CSU
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