Amneal Submits BLA for Biosimilar to XOLAIR (Omalizumab)

Amneal Pharmaceuticals, Inc. has announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for a proposed biosimilar to XOLAIR® (omalizumab). This biosimilar candidate was developed by Kashiv BioSciences, LLC. XOLAIR® is a registered trademark of Novartis AG.

About Omalizumab (XOLAIR®)

Drug Type: Omalizumab is a humanized monoclonal antibody that specifically targets free IgE (Immunoglobulin E).
Approved Indications:
- Treatment of moderate to severe persistent asthma (for patients 6 years and older).
- Chronic rhinosinusitis with nasal polyps (CRSwNP) (for patients 18 years and older).
- Food allergies (for patients >1 year and older).
- Chronic spontaneous urticaria (for patients 12 years and older).
Black Box Warning: Omalizumab carries a black boxed warning for anaphylaxis, which can occur after any dose, including the first. Due to this risk, the drug should be initiated and administered in a healthcare setting with close patient observation. It is contraindicated in patients with severe hypersensitivity reactions to the drug.

Strategic Importance for Amneal

Growth Catalyst: Amneal views this biosimilar candidate as a significant potential growth catalyst, aiming to be among the first wave of omalizumab biosimilars in the market.
Expanding Biosimilar Portfolio: This submission aligns with Amneal’s strategy to expand its biosimilar offerings. The company expects another five biosimilar launches from 2026 to 2027, including this omalizumab biosimilar, which are positioned as key growth drivers.
Partnership with Kashiv BioSciences: Kashiv BioSciences, already known for marketed biosimilars like RELEUKO® (filgrastim-ayow) and FYLNETRA® (pegfilgrastim-pbbk), emphasizes its commitment to providing cost-effective, high-quality medicines through strategic partnerships and its U.S.-based manufacturing and marketing capabilities.