Amneal Pharmaceuticals, Inc.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), developed by Kashiv BioSciences, LLC. XOLAIR^® is a registered trademark of Novartis AG.

Omalizumab, a humanized monoclonal antibody that targets free IgE, is indicated for the treatment of moderate to severe persistent asthma (6 years and older patients), chronic rhinosinusitis with nasal polyps (CRSwNP) (18 years and older patients), food allergies (>1 year and older patients), and chronic spontaneous urticaria (12 years and older patients).

Omalizumab has a black boxed warning of anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of the first dose and beyond one year during regularly administered treatment. The drug should be initiated and administered in a healthcare setting (hospital or clinic setting) and patients should be closely observed for an appropriate period of time after administration, and if occurs, anaphylaxis should be managed. It is contraindicated in patients with severe hypersensitivity reaction to the drug or any ingredient contained in the product.

“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. Alongside our three marketed biosimilars, we expect another five biosimilar launches from 2026 to 2027, including our biosimilar to XOLAIR, positioning biosimilars as a key growth driver for Amneal.”

“Kashiv continues to execute strongly on our expanding biosimilar portfolio, which already includes RELEUKO^® (filgrastim-ayow) and FYLNETRA^®(pegfilgrastim-pbbk). This BLA submission represents an important milestone in making our omalizumab biosimilar available to patients,” said Dr. Sandeep Athalye, Chief Executive Officer at Kashiv BioSciences. “Kashiv is proud to be one of the U.S.-based companies having manufacturing as well as marketing authorizations for multiple biosimilars, reflecting our commitment to cost-effective, high-quality medicines through strong partnerships.”

According to IQVIA^®, U.S. annual sales for XOLAIR^® totaled approximately $4.1 billion for the 12 months ending July 2025.

As a result of the earlier BLA filing, Amneal expects to incur a $22.5 million R&D milestone charge in the third quarter of 2025, rather than the fourth quarter as previously expected. This cost was included in the company’s financial guidance. Amneal holds exclusive U.S. commercialization rights for the product, pending regulatory approval.

Note: XOLAIR^® is a registered trademark of Novartis AG.