Amneal Pharmaceuticals has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for a proposed biosimilar to XOLAIR (omalizumab), marking a significant milestone in the company's biosimilar portfolio expansion. The biosimilar candidate was developed by Kashiv BioSciences, LLC, with Amneal holding exclusive U.S. commercialization rights pending regulatory approval.
The submission comes earlier than expected and positions Amneal for potential first-wave entry into what represents a substantial market opportunity. According to IQVIA data, U.S. annual sales for XOLAIR totaled approximately $4.1 billion for the 12 months ending July 2025.
Therapeutic Profile and Market Opportunity
Omalizumab is a humanized monoclonal antibody that targets free IgE and is indicated for multiple therapeutic areas. The drug is approved for the treatment of moderate to severe persistent asthma in patients 6 years and older, chronic rhinosinusitis with nasal polyps (CRSwNP) in patients 18 years and older, food allergies in patients over 1 year old, and chronic spontaneous urticaria in patients 12 years and older.
The medication carries a black box warning for anaphylaxis, which can present as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue. These reactions have been reported to occur after administration of the first dose and beyond one year during regularly administered treatment. The drug must be initiated and administered in a healthcare setting, with patients closely observed for an appropriate period after administration.
Strategic Significance for Amneal
"The earlier-than-expected BLA submission for this important therapeutic is excellent news for Amneal, as this product represents a significant potential growth catalyst in the coming years," said Andy Boyer, Executive Vice President and Chief Commercial Officer, Affordable Medicines at Amneal Pharmaceuticals. "We are excited about the opportunity to be part of the first wave of omalizumab biosimilars in this large and attractive market."
The omalizumab biosimilar represents part of a broader biosimilar expansion strategy for Amneal. Boyer noted that alongside their three currently marketed biosimilars, the company expects another five biosimilar launches from 2026 to 2027, including their biosimilar to XOLAIR, positioning biosimilars as a key growth driver for Amneal.
Partnership with Kashiv BioSciences
The collaboration with Kashiv BioSciences reflects the partner company's growing biosimilar capabilities. "Kashiv continues to execute strongly on our expanding biosimilar portfolio, which already includes RELEUKO (filgrastim-ayow) and FYLNETRA (pegfilgrastim-pbbk)," said Dr. Sandeep Athalye, Chief Executive Officer at Kashiv BioSciences. "This BLA submission represents an important milestone in making our omalizumab biosimilar available to patients."
Kashiv BioSciences operates as a vertically integrated biopharmaceutical company with facilities in both the USA and India, providing global research and development, clinical, manufacturing, regulatory, and intellectual property capabilities.
Financial Impact
As a result of the earlier BLA filing timeline, Amneal expects to incur a $22.5 million research and development milestone charge in the third quarter of 2025, rather than the fourth quarter as previously anticipated. This cost was already included in the company's financial guidance, indicating the submission was planned but accelerated ahead of schedule.
