Builds on successful U.S. biosimilar partnership of 2 oncology
products (RELEUKO® & FYLNETRA®)
ADL018 is Kashiv’s lead pipeline biosimilar program, currently
in Phase III
Kashiv BioSciences, LLC (“Kashiv” or the “Company”) today
announced that it has entered into an exclusive licensing agreement
for ADL018, a proposed biosimilar to omalizumab referencing
XOLAIR®, with Amneal Pharmaceuticals, Inc. (“Amneal”) for the
United States.
Omalizumab, which targets free IgE, is a humanized monoclonal
antibody. It is an injectable prescription drug used to treat a
number of chronic conditions such as severe persistent allergic
asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), food
allergies, and chronic spontaneous urticaria, and is typically
administered in a hospital or clinic setting. The biosimilar was
developed by Kashiv BioSciences, LLC and is currently in a Phase
III clinical trial, which began in the third quarter of 2023.
“We are pleased to partner with Amneal, a leader in
commercialization of biologics in the US, on our most advanced
pipeline product, ADL018, a proposed biosimilar to XOLAIR®. We are
building on our highly productive partnership with the commercial
success of RELEUKO® & FYLNETRA®. Kashiv is one of a few
companies based in the United States to manufacture and receive
marketing authorization of multiple biosimilars. By relentlessly
focusing on quality and cost-effective development, Kashiv
continues to build upon its strong track record of developing and
manufacturing high-quality, affordable biosimilars to improve
patients’ lives worldwide,” said Dr. Sandeep Gupta, Chief Executive
Officer of Kashiv.
“We are excited to further grow our biosimilar portfolio with
the addition of omalizumab and expand into a new therapeutic area
beyond oncology. We are building on the strong success of our first
commercial biosimilars. Amneal is committed to providing affordable
biologic medicines which will increase access and choice to
patients and providers, and drive cost savings to the U.S.
healthcare system,” said Sean McGowan, Vice President, Biosimilars
and Branded Oncology.
According to IQVIA®, U.S. annual sales for XOLAIR® for the 12
months ended April 2024 were approximately $3.2 billion. XOLAIR® is
a registered trademark of Novartis AG.
The financial terms of the transaction were not disclosed, and
any incremental expenses associated with these products are
contemplated within Amneal’s guidance.
About Kashiv Biosciences, LLC
Kashiv Biosciences, LLC is a fully integrated biopharmaceutical
company with global R&D, clinical, regulatory, and
manufacturing capabilities for developing biosimilars and other
complex products. The Company has a robust pipeline of 7+
biosimilars, and multiple 505(b)(2) and complex peptide generic
products in development. Kashiv is headquartered in Piscataway, NJ
with FDA-approved GMP manufacturing facilities in Chicago, IL and
state-of-the-art R&D infrastructure in Ahmedabad, India. For
more information, visit www.kashivbiosciences.com.
About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in
Bridgewater, NJ, is a global pharmaceuticals company. We make
healthy possible through the development, manufacturing, and
distribution of a diverse portfolio of over 280 pharmaceutical
products, primarily within the United States. In its Generics
segment, Amneal 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, with a pipeline focused on
unmet needs. Through its AvKARE segment, Amneal 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240702506268/en/
Dr. Paras Vasanani Head of BD&L, Portfolio Strategy
paras.vasanani@kashivbio.com Anthony DiMeo VP, Investor Relations
& Media anthony.dimeo@amneal.com
Amneal Pharmaceuticals (NYSE:AMRX)
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