In October 2025, Kashiv BioSciences announced an advance in its pipeline, submitting a biologics license application (BLA) for ADL-018, a proposed biosimilar to Xolair (omalizumab), to the FDA. Simultaneously, the European Medicines Agency accepted the marketing authorization application for ADL-018. Omalizumab, a humanized monoclonal antibody, is indicated for individuals experiencing conditions such as chronic spontaneous urticaria, moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, and IgE-mediated food allergy.
This therapeutic market is large, with global annual sales for the reference product totaling approximately $5.5 billion for the 12 months ending in June 2025, including $4.1 billion in the US and $1.0 billion in the European Union.
Kashiv is developing ADL-018 in partnership with Alvotech. Kashiv’s BLA submission positions ADL-018 to be among the first wave of biosimilar entrants in this large market. Amneal Pharmaceuticals, a partner, anticipated that the product would serve as a significant growth catalyst and announced plans to launch 5 additional biosimilars between 2026 and 2027, highlighting biosimilars as a critical growth driver for the company.
Continue at: https://www.centerforbiosimilars.com/view/global-biosimilars-market-sees-gains-in-access-and-pipeline-expansion
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