Amneal Announces BLA Submission of Biosimilar Candidate to XOLAIR® (omalizumab)

Rhea-AI Summary

Amneal Pharmaceuticals (Nasdaq: AMRX) has submitted a Biologics License Application (BLA) to the FDA for a proposed biosimilar to XOLAIR® (omalizumab), developed by Kashiv BioSciences. The submission came earlier than expected for this therapeutic targeting the $4.1 billion U.S. market.

The biosimilar aims to treat moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, food allergies, and chronic spontaneous urticaria. This represents Amneal's potential first-wave entry into the omalizumab market, adding to their portfolio of three marketed biosimilars, with five more launches planned for 2026-2027.

Due to the early submission, Amneal will incur a $22.5 million R&D milestone charge in Q3 2025 instead of Q4, which was already included in their financial guidance.

Positive

• Earlier than expected BLA submission to FDA for XOLAIR biosimilar
• Potential first-wave entry into $4.1 billion U.S. market
• Part of expanding biosimilar portfolio with 5 more launches planned for 2026-2027
• Exclusive U.S. commercialization rights for the product

Negative

• $22.5 million R&D milestone charge to be incurred in Q3 2025
• Product carries black box warning for risk of anaphylaxis
• Requires administration in healthcare setting with post-administration observation period

Insights

Pharmaceutical Industry Analyst

Amneal's early BLA for XOLAIR biosimilar creates first-mover advantage in $4.1B market, bolstering biosimilar portfolio expansion strategy.

Amneal's earlier-than-expected BLA submission for its omalizumab biosimilar represents a strategic advancement in the company's growing biosimilar portfolio. This submission positions Amneal to potentially secure first-wave entry into the substantial $4.1 billion U.S. XOLAIR market. The timing advantage could be crucial in the competitive biosimilar landscape, where earlier market entrants typically secure higher market share and better pricing.

The omalizumab opportunity aligns with Amneal's broader biosimilar strategy, which includes three currently marketed products and five additional launches planned for 2026-2027. This expanding portfolio diversifies revenue streams away from traditional generic products, which face persistent pricing pressure. Biosimilars generally offer higher margins and longer commercial lifecycles than small-molecule generics.

While the accelerated submission triggers an earlier $22.5 million R&D milestone payment in Q3 2025 rather than Q4, this expense was already incorporated into financial guidance. The partnership structure with Kashiv BioSciences—where Amneal holds exclusive U.S. commercialization rights—allows Amneal to leverage external R&D expertise while maintaining control over the commercial opportunity in the world's largest pharmaceutical market.

Omalizumab's multiple indications (asthma, chronic rhinosinusitis with nasal polyps, food allergies, and chronic spontaneous urticaria) across different age groups provides diverse market opportunities. However, the product's black box warning for anaphylaxis and requirement for administration in healthcare settings may influence adoption dynamics compared to self-administered biologics.

Potential first-wave entry into the $4+ billion U.S. market and an important new growth driver for Amneal

BRIDGEWATER, N.J., Sept. 26, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today 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.

About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com and follow us on LinkedIn.

About Kashiv BioSciences
Kashiv BioSciences, LLC is a vertically integrated biopharmaceutical company with numerous commercial and advanced clinical-stage assets. Kashiv BioSciences, LLC in the USA, and its subsidiaries in India (together “Kashiv BioSciences”) operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines.

Cautionary Statement on Forward-Looking Statements
Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

Investor Contact
Anthony DiMeo
VP, Investor Relations
anthony.dimeo@amneal.com

Media Contact
Brandon Skop
Sr. Director, Corporate Communications
brandon.skop@amneal.com

Kashiv BioSciences Contact:
Dr. Paras Vasanani
Global Head of Business Development, Portfolio & Strategy
paras.vasanani@kashivbio.com
https://www.kashivbiosciences.com/

FAQ

What is the market size for XOLAIR that Amneal's biosimilar is targeting?

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

What conditions will Amneal's XOLAIR biosimilar treat?

The biosimilar will treat moderate to severe persistent asthma (6+ years), chronic rhinosinusitis with nasal polyps (18+ years), food allergies (1+ year), and chronic spontaneous urticaria (12+ years).

How will the early BLA submission affect Amneal's financials in 2025?

Amneal will incur a $22.5 million R&D milestone charge in Q3 2025 instead of Q4 2025, though this cost was already included in the company's financial guidance.

How many biosimilar products does Amneal plan to launch in 2026-2027?

Amneal plans to launch five biosimilar products between 2026 and 2027, including their biosimilar to XOLAIR®.

What are the safety concerns with XOLAIR biosimilar?

The drug carries a black box warning for anaphylaxis risk and must be administered in a healthcare setting with patient observation. It's contraindicated in patients with severe hypersensitivity to the drug or its ingredients.