Kashiv BioSciences Enters into Exclusive Licensing Agreement with Amneal for Commercialization of a Proposed Biosimilar to XOLAIR® (Omalizumab)
Builds on successful
ADL018 is Kashiv’s lead pipeline biosimilar program, currently in Phase III
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
“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
According to IQVIA®,
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
About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in
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Dr. Paras Vasanani
Head of BD&L, Portfolio Strategy
paras.vasanani@kashivbio.com
Anthony DiMeo
VP, Investor Relations & Media
anthony.dimeo@amneal.com
Source: Kashiv BioSciences, LLC