• Kashiv Biosciences has submitted its Biologics License Applications (BLA) for ADL-018 as a biosimilar to reference product XOLAIR® (omalizumab) to the U.S. Food and Drug Administration (FDA)
• The Marketing Authorization Application (MAA) for ADL-018 as a biosimilar to XOLAIR^® (omalizumab) has been accepted by the European Medicines Agency (EMA)
• Long-term growth opportunity given potential to be among the first-wave of biosimilar entrants in the ~$5.5+ billion global, ~$4.0+ billion U.S., and ~$1.0+ billion E.U. omalizumab market

Kashiv BioSciences, LLC, a fully-integrated biopharmaceutical company, announced that they have submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA), for ADL-018, a proposed biosimilar to XOLAIR^® (omalizumab).

The submissions are intended to seek approval in the United States and the European Economic Area, respectively. 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), chronic spontaneous urticaria (12 years and older patients), and IgE-mediated food allergy (>1 year and older patients).

“Kashiv continues to execute strongly on our expanding biosimilar portfolio, which already includes RELEUKO^® (filgrastim-ayow) and FYLNETRA^® (pegfilgrastim-pbbk). The BLA and EMA 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.”

“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.”

According to IQVIA^®, global, U.S., and E.U. annual sales for XOLAIR^® totaled approximately ~$5.5 billion, ~$4.1 billion, and ~$1.0 billion, respectively, for the 12 months ending June 2025.

Alvotech partnered with Kashiv BioSciences for the development of the proposed XOLAIR^® biosimilar, which is referred to as AVT23 by Alvotech and as ADL-018 by Kashiv Biosciences.

Use of trademarks

XOLAIR^® is a registered trademark of Novartis AG.

About ADL-018

ADL-018, a humanized monoclonal antibody designed to inhibit the binding of IgE to FcεR on the surface of mast cells and basophils, is being developed as a biosimilar to XOLAIR^® (omalizumab), an injectable prescription medicine approved to treat CSU in individuals aged 12 and older who continue to have hives uncontrolled by H1 antagonists. Omalizumab is also approved for treating moderate to severe persistent asthma in individuals aged 6 and older whose asthma symptoms are not well controlled with inhaled corticosteroids, chronic rhinosinusitis with nasal polyps in individuals aged 18 and older, and IgE-mediated food allergy in adult and pediatric patients aged 1 year and older.

ADL-018 matches the pharmaceutical presentations, dosage strength, route of administration, and dosing regimen of the U.S. and E.U.-approved omalizumab reference product. XOLAIR^® is a registered trademark of Novartis AG.

Alvotech partnered with Kashiv BioSciences for the development of the proposed XOLAIR^® biosimilar for the market in the European Economic Area, UK, Switzerland, Australia New Zealand and Canada.

About Kashiv BioSciences:

Kashiv BioSciences, LLC is a vertically integrated biopharmaceutical company with numerous commercial and advanced clinical-stage assets and is among the few U.S.-based companies to both manufacture and receive marketing authorization for multiple biosimilars. 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.

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 Alvotech

Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Two biosimilars, to Humira® (adalimumab) and Stelara® (ustekinumab) are already approved and marketed in multiple global markets. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.

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"The BLA and EMA submission represents an important milestone in making our omalizumab biosimilar available to patients,” said Dr. Sandeep Athalye, Chief Executive Officer at Kashiv BioSciences.