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Kashiv Biosciences submits a BLA to the US FDA and receives EMA MAA acceptance for ADL-018 (Biosimilar, Xolair) 

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  • Kashiv BioSciences submitted a BLA to the US FDA and received EMA MAA acceptance for ADL-018, a proposed biosimilar to Xolair (omalizumab) 
  • ADL-018 is a humanized mAb biosimilar to Xolair (omalizumab), designed to block IgE binding on mast cells and basophils. Xolair is approved for CSU (≥12 yrs), moderate-to-severe asthma (≥6 yrs), chronic rhinosinusitis with nasal polyps (≥18 yrs), and IgE-mediated food allergy (≥1 yr) 
  • Alvotech partnered with Kashiv BioSciences to develop the proposed Xolair biosimilar known as AVT23 by Alvotech and ADL-018 by Kashiv for markets including the EEA, UK, Switzerland, Australia, New Zealand, and Canada 

Ref: Businesswire| Image: Kashiv BioSciences | Press Release

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