{"id":863577,"date":"2025-06-25T08:50:35","date_gmt":"2025-06-25T12:50:35","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/amneal-highlights-positive-topline-results-from-confirmatory-clinical-study-of-biosimilar-candidate-to-xolairr-omalizumab-developed-by-kashiv-biosciences\/"},"modified":"2025-06-25T08:50:35","modified_gmt":"2025-06-25T12:50:35","slug":"amneal-highlights-positive-topline-results-from-confirmatory-clinical-study-of-biosimilar-candidate-to-xolairr-omalizumab-developed-by-kashiv-biosciences","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/amneal-highlights-positive-topline-results-from-confirmatory-clinical-study-of-biosimilar-candidate-to-xolairr-omalizumab-developed-by-kashiv-biosciences\/","title":{"rendered":"Amneal Highlights Positive Topline Results from Confirmatory Clinical Study of Biosimilar Candidate to XOLAIR(R) (omalizumab), Developed by Kashiv BioSciences"},"content":{"rendered":"
\n

\n Amneal holds exclusive U.S. commercialization rights; BLA filing expected in Q4 2025<\/em>\n <\/p>\n

\n Poised to be among the first wave of biosimilars in the $3.9 billion U.S. omalizumab market and an important growth driver for Amneal<\/em>\n <\/p>\n

BRIDGEWATER, N.J., June 25, 2025 (GLOBE NEWSWIRE) — Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (\u201cAmneal\u201d or the \u201cCompany\u201d) today highlighted positive topline results from a confirmatory clinical efficacy and safety clinical trial evaluating ADL-018, a proposed biosimilar to XOLAIR\u00ae<\/sup> (omalizumab), developed by Kashiv BioSciences, LLC. The randomized, double-blind, multicenter study was conducted by Kashiv to assess the efficacy, safety, and immunogenicity of ADL-018 compared to XOLAIR\u00ae<\/sup> in patients with Chronic Idiopathic Urticaria (CIU) or Chronic Spontaneous Urticaria (CSU) who remained symptomatic despite treatment with H1 antihistamines.<\/p>\n

Omalizumab, a humanized monoclonal antibody that targets free IgE, is indicated for the treatment of severe allergic asthma (>6 years old), chronic rhinosinusitis with nasal polyps (CRSwNP) (>18 years old), food allergies (>1 year old), and chronic spontaneous urticaria (>12 years old). It is typically administered in a hospital or clinic setting. The clinical study achieved its primary and secondary endpoints by establishing equivalence of therapeutic endpoints and comparable safety between ADL-018 and XOLAIR\u00ae<\/sup>. Participants received subcutaneous doses of either 150 mg or 300 mg every four weeks for a 24-week period. A total of 600 patients were enrolled, and efficacy and safety were evaluated in 400 patients who received the confirmatory dose of 300 mg. The primary efficacy measure was the change from baseline in the weekly itch severity score (ISS7) at Week 12 between the treatment arms of ADL-018 and the reference product.<\/p>\n

\u201cWe are pleased with the positive Phase 3 results for ADL-018, which represents an important step towards making a biosimilar to XOLAIR\u00ae<\/sup> available to U.S. patients,\u201d said Sean McGowan, Senior Vice President, Biosimilars and Branded Oncology at Amneal Pharmaceuticals. \u201cPending FDA approval, we believe this will be a key addition to our biosimilars portfolio and part of our broader strategy to commercialize six biosimilars across eight product presentations by 2027.\u201d<\/p>\n

\u201cThis marks a positive advancement for Kashiv\u2019s growing biosimilar pipeline in addition to its current portfolio of RELEUKO\u00ae<\/sup> (filgrastim-ayow) and FYLNETRA\u00ae<\/sup> (pegfilgrastim-pbbk). We look forward to collaborating with regulatory authorities to make this treatment available to patients,\u201d said Dr. Sandeep Athalye, Chief Executive Officer at Kashiv BioSciences. \u201cKashiv is among the few U.S.-based companies to both manufacture and receive marketing authorization for multiple biosimilars. We remain focused on delivering cost-effective, high-quality therapies to improve patient outcomes globally, working with commercial partners such as Amneal.\u201d<\/p>\n

A Biologics License Application (BLA) for this product is expected to be submitted to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2025 by Kashiv BioSciences. Amneal holds exclusive U.S. commercialization rights for the product, pending regulatory approval.<\/p>\n

According to IQVIA\u00ae<\/sup>, U.S. annual sales for XOLAIR\u00ae<\/sup> totaled approximately $3.9 billion for the 12 months ending April 2025. XOLAIR\u00ae<\/sup> is a registered trademark of Novartis AG.<\/p>\n

\n About Amneal<\/strong>
\n
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\u00a0www.amneal.com<\/a> and follow us on LinkedIn<\/a>.<\/p>\n

\n About Kashiv BioSciences<\/strong>
\n
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 \u201cKashiv BioSciences\u201d) 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.<\/p>\n

\n Cautionary Statement on Forward-Looking Statements<\/strong>
\n
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\u2019s 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 \u201cplans,\u201d \u201cexpects,\u201d \u201cwill,\u201d \u201canticipates,\u201d \u201cestimates,\u201d 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\u2019s filings with the Securities and Exchange Commission, including under Item 1A, \u201cRisk Factors\u201d in the Company\u2019s 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.<\/p>\n

\n Investor Contact <\/strong>
\n
Anthony DiMeo
VP, Investor Relations
anthony.dimeo@amneal.com<\/a><\/p>\n

Media Contact<\/strong>
Brandon Skop
Sr. Director, Corporate Communications
Brandon.skop@amneal.com<\/a><\/p>\n

\n Kashiv BioSciences Contact:<\/strong>
\n
Dr. Paras Vasanani
Head of Business Development
paras.vasanani@kashivbio.com<\/a>
https:\/\/www.kashivbiosciences.com\/<\/a><\/p>\n

\"\"
\n
\n \"\"\n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

Amneal holds exclusive U.S. commercialization rights; BLA filing expected in Q4 2025 Poised to be among the first wave of biosimilars in the $3.9 billion U.S. omalizumab market and an important growth driver for Amneal BRIDGEWATER, N.J., June 25, 2025 (GLOBE NEWSWIRE) — Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (\u201cAmneal\u201d or the \u201cCompany\u201d) today highlighted positive topline results from a confirmatory clinical efficacy and safety clinical trial evaluating ADL-018, a proposed biosimilar to XOLAIR\u00ae (omalizumab), developed by Kashiv BioSciences, LLC. The randomized, double-blind, multicenter study was conducted by Kashiv to assess the efficacy, safety, and immunogenicity of ADL-018 compared to XOLAIR\u00ae in patients with Chronic Idiopathic Urticaria (CIU) or Chronic Spontaneous Urticaria (CSU) who remained symptomatic despite treatment with H1 antihistamines. … <\/p>\n

Continue reading “Amneal Highlights Positive Topline Results from Confirmatory Clinical Study of Biosimilar Candidate to XOLAIR(R) (omalizumab), Developed by Kashiv BioSciences”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-863577","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nAmneal Highlights Positive Topline Results from Confirmatory Clinical Study of Biosimilar Candidate to XOLAIR(R) (omalizumab), Developed by Kashiv BioSciences - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/amneal-highlights-positive-topline-results-from-confirmatory-clinical-study-of-biosimilar-candidate-to-xolairr-omalizumab-developed-by-kashiv-biosciences\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Amneal Highlights Positive Topline Results from Confirmatory Clinical Study of Biosimilar Candidate to XOLAIR(R) (omalizumab), Developed by Kashiv BioSciences - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Amneal holds exclusive U.S. commercialization rights; BLA filing expected in Q4 2025 Poised to be among the first wave of biosimilars in the $3.9 billion U.S. omalizumab market and an important growth driver for Amneal BRIDGEWATER, N.J., June 25, 2025 (GLOBE NEWSWIRE) — Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (\u201cAmneal\u201d or the \u201cCompany\u201d) today highlighted positive topline results from a confirmatory clinical efficacy and safety clinical trial evaluating ADL-018, a proposed biosimilar to XOLAIR\u00ae (omalizumab), developed by Kashiv BioSciences, LLC. The randomized, double-blind, multicenter study was conducted by Kashiv to assess the efficacy, safety, and immunogenicity of ADL-018 compared to XOLAIR\u00ae in patients with Chronic Idiopathic Urticaria (CIU) or Chronic Spontaneous Urticaria (CSU) who remained symptomatic despite treatment with H1 antihistamines. … Continue reading "Amneal Highlights Positive Topline Results from Confirmatory Clinical Study of Biosimilar Candidate to XOLAIR(R) (omalizumab), Developed by Kashiv BioSciences"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/amneal-highlights-positive-topline-results-from-confirmatory-clinical-study-of-biosimilar-candidate-to-xolairr-omalizumab-developed-by-kashiv-biosciences\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-06-25T12:50:35+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQ4MzIwMSM3MDE0Mjg0IzIxOTA3Mzc=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/amneal-highlights-positive-topline-results-from-confirmatory-clinical-study-of-biosimilar-candidate-to-xolairr-omalizumab-developed-by-kashiv-biosciences\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/amneal-highlights-positive-topline-results-from-confirmatory-clinical-study-of-biosimilar-candidate-to-xolairr-omalizumab-developed-by-kashiv-biosciences\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Amneal Highlights Positive Topline Results from Confirmatory Clinical Study of Biosimilar Candidate to XOLAIR(R) (omalizumab), Developed by Kashiv BioSciences\",\"datePublished\":\"2025-06-25T12:50:35+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/amneal-highlights-positive-topline-results-from-confirmatory-clinical-study-of-biosimilar-candidate-to-xolairr-omalizumab-developed-by-kashiv-biosciences\\\/\"},\"wordCount\":934,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/amneal-highlights-positive-topline-results-from-confirmatory-clinical-study-of-biosimilar-candidate-to-xolairr-omalizumab-developed-by-kashiv-biosciences\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTQ4MzIwMSM3MDE0Mjg0IzIxOTA3Mzc=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/amneal-highlights-positive-topline-results-from-confirmatory-clinical-study-of-biosimilar-candidate-to-xolairr-omalizumab-developed-by-kashiv-biosciences\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/amneal-highlights-positive-topline-results-from-confirmatory-clinical-study-of-biosimilar-candidate-to-xolairr-omalizumab-developed-by-kashiv-biosciences\\\/\",\"name\":\"Amneal Highlights Positive Topline Results from Confirmatory Clinical Study of Biosimilar Candidate to XOLAIR(R) (omalizumab), Developed by Kashiv BioSciences - 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(Nasdaq: AMRX) (\u201cAmneal\u201d or the \u201cCompany\u201d) today highlighted positive topline results from a confirmatory clinical efficacy and safety clinical trial evaluating ADL-018, a proposed biosimilar to XOLAIR\u00ae (omalizumab), developed by Kashiv BioSciences, LLC. The randomized, double-blind, multicenter study was conducted by Kashiv to assess the efficacy, safety, and immunogenicity of ADL-018 compared to XOLAIR\u00ae in patients with Chronic Idiopathic Urticaria (CIU) or Chronic Spontaneous Urticaria (CSU) who remained symptomatic despite treatment with H1 antihistamines. … Continue reading \"Amneal Highlights Positive Topline Results from Confirmatory Clinical Study of Biosimilar Candidate to XOLAIR(R) (omalizumab), Developed by Kashiv BioSciences\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/amneal-highlights-positive-topline-results-from-confirmatory-clinical-study-of-biosimilar-candidate-to-xolairr-omalizumab-developed-by-kashiv-biosciences\/","og_site_name":"Market Newsdesk","article_published_time":"2025-06-25T12:50:35+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQ4MzIwMSM3MDE0Mjg0IzIxOTA3Mzc=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/amneal-highlights-positive-topline-results-from-confirmatory-clinical-study-of-biosimilar-candidate-to-xolairr-omalizumab-developed-by-kashiv-biosciences\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/amneal-highlights-positive-topline-results-from-confirmatory-clinical-study-of-biosimilar-candidate-to-xolairr-omalizumab-developed-by-kashiv-biosciences\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Amneal Highlights Positive Topline Results from Confirmatory Clinical Study of Biosimilar Candidate to XOLAIR(R) (omalizumab), Developed by Kashiv BioSciences","datePublished":"2025-06-25T12:50:35+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/amneal-highlights-positive-topline-results-from-confirmatory-clinical-study-of-biosimilar-candidate-to-xolairr-omalizumab-developed-by-kashiv-biosciences\/"},"wordCount":934,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/amneal-highlights-positive-topline-results-from-confirmatory-clinical-study-of-biosimilar-candidate-to-xolairr-omalizumab-developed-by-kashiv-biosciences\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQ4MzIwMSM3MDE0Mjg0IzIxOTA3Mzc=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/amneal-highlights-positive-topline-results-from-confirmatory-clinical-study-of-biosimilar-candidate-to-xolairr-omalizumab-developed-by-kashiv-biosciences\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/amneal-highlights-positive-topline-results-from-confirmatory-clinical-study-of-biosimilar-candidate-to-xolairr-omalizumab-developed-by-kashiv-biosciences\/","name":"Amneal Highlights Positive Topline Results from Confirmatory Clinical Study of Biosimilar Candidate to XOLAIR(R) (omalizumab), Developed by Kashiv BioSciences - 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