Kashiv Biosciences Announces Submission of Biologics License Application to U.S. FDA and Acceptance of Market Authorization Application by European Medicines Agency for ADL-018, a Proposed Biosimilar to XOLAIR® (omalizumab)
MWN-AI** Summary
Kashiv Biosciences has made significant strides in the biopharmaceutical sector with the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and the acceptance of a Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for ADL-018, a proposed biosimilar to XOLAIR® (omalizumab). These applications aim to secure approval for ADL-018 in the U.S. and the European Economic Area, respectively.
XOLAIR® is a monoclonal antibody used to treat various conditions, including moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, and certain allergies. The global market for omalizumab is substantial, exceeding $5.5 billion, with around $4 billion coming from the U.S. and over $1 billion from Europe. Kashiv’s entry into this market as a potential first-wave biosimilar provider represents a lucrative growth opportunity.
Dr. Sandeep Athalye, CEO of Kashiv, highlighted the company's commitment to expanding its biosimilar portfolio, which also includes several other biosimilars like RELEUKO® and FYLNETRA®. Meanwhile, Andy Boyer from Amneal Pharmaceuticals emphasized that the early BLA submission for ADL-018 is a positive development, marking it as a strategic growth catalyst in the upcoming years.
The development of ADL-018 is in collaboration with Alvotech, which is working to establish a presence in the biosimilar market for XOLAIR® across multiple regions, including the U.K. and Canada. Kashiv's infrastructure and expertise position it favorably for success, reinforcing its mission to provide cost-effective, high-quality healthcare solutions. This development could be pivotal as it aligns with broader market trends toward biosimilars, promising greater patient access to essential therapies.
MWN-AI** Analysis
Kashiv Biosciences' recent announcement regarding the submission of a Biologics License Application (BLA) for ADL-018, its proposed biosimilar to XOLAIR® (omalizumab), presents a compelling investment opportunity amid the growing biosimilar market. With an estimated global market exceeding $5.5 billion, and U.S. and E.U. segments valued at over $4 billion and $1 billion, respectively, ADL-018 positions Kashiv strategically to capitalize on the impending wave of generic competitors to established biologics.
The acceptance of the Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) adds an additional layer of credibility, indicating a well-prepared entry into the European market. Given that XOLAIR® is an established treatment for severe asthma, chronic rhinosinusitis, and other conditions, the demand for a cost-effective biosimilar is poised to increase, especially as healthcare systems globally seek to control rising pharmaceutical costs.
Investors should note that Kashiv's robust and vertically integrated structure allows for both manufacturing and marketing of multiple biosimilars, which may mitigate risks associated with dependence on third-party suppliers. The company’s partnerships, including its collaboration with Alvotech, further enhance its market positioning by leveraging combined expertise to streamline development and distribution.
As the biosimilars segment is expected to drive growth for protagonists like Amneal Pharmaceuticals, whose leadership acknowledged the product as a significant growth catalyst, Kashiv is similarly well-positioned to emerge as a competitive player. Furthermore, with additional biosimilars slated for launch by 2026-2027, stakeholders could look forward to a sustained influx of revenue-generating products.
Investors would do well to closely monitor the progress of ADL-018's approval and market entry, as successful commercialization could significantly enhance Kashiv Biosciences' valuation. The potential impact of biosimilars on healthcare economics offers an intriguing angle for future growth in the biopharmaceutical sector.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
- 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 Fc?R 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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View source version on businesswire.com: https://www.businesswire.com/news/home/20250930481480/en/
Kashiv BioSciences Contact:
Dr. Paras Vasanani
Chief Business Officer & SVP – Business Development, Portfolio & Strategy
paras.vasanani@kashivbio.com
https://www.kashivbiosciences.com/
Amneal Pharmaceuticals Contact:
Anthony DiMeo
VP, Investor Relations
anthony.dimeo@amneal.com
Alvotech Contact:
Benedikt Stefansson
VP, Investor Relations and Global Communications
alvotech.ir@alvotech.com
FAQ**
How does the partnership with Alvotech (Alvotech ALVO) enhance Kashiv BioSciences' ability to compete in the growing biosimilar market, particularly for the product ADL-018?
What impact do you anticipate the approval of ADL-018 as a biosimilar to XOLAIR will have on Kashiv BioSciences' revenue projections in the next five years, considering Alvotech's involvement?
Could you elaborate on the strategic relationship between Kashiv BioSciences and Alvotech (Alvotech ALVO) in bringing ADL-018 to market in Europe and the U.S., and how might this affect your competitive positioning?
What are the expected timelines and regulatory hurdles for ADL-018 to reach the market, especially with Alvotech ALVO's involvement, and how do you plan to navigate them?
**MWN-AI FAQ is based on asking OpenAI questions about Alvotech (NASDAQ: ALVO).
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