Kashiv BioSciences Enters into Exclusive Licensing Agreement with Amneal for Commercialization of a Proposed Biosimilar to XOLAIR® (Omalizumab)
Kashiv BioSciences has entered into an exclusive licensing agreement with Amneal Pharmaceuticals for the U.S. commercialization of ADL018, a proposed biosimilar to XOLAIR® (omalizumab).
ADL018 is currently in Phase III clinical trials, which began in Q3 2023. Omalizumab, a monoclonal antibody targeting IgE, is used to treat conditions like severe allergic asthma and chronic rhinosinusitis with nasal polyps.
This collaboration builds on the successful U.S. biosimilar partnership between the two companies for oncology products RELEUKO® and FYLNETRA®.
Annual U.S. sales for XOLAIR® were approximately $3.2 billion as of April 2024. Financial terms of the agreement were not disclosed.
- Exclusive licensing agreement with Amneal for ADL018 in the U.S. market.
- ADL018 is in Phase III clinical trials, a important step towards market approval.
- The current U.S. market for XOLAIR® is valued at approximately $3.2 billion annually.
- Success builds on previous collaborations for RELEUKO® and FYLNETRA®.
- Potential expansion into new therapeutic areas beyond oncology.
- No disclosure of financial terms or specific revenue projections.
The exclusive licensing agreement between Kashiv BioSciences and Amneal Pharmaceuticals for a proposed biosimilar to XOLAIR® (omalizumab) holds significant financial implications for both companies. XOLAIR® is a major product with annual sales of
Investors should consider the market dynamics of biosimilars. Unlike generic drugs, biosimilars are clinically equivalent but are not exact copies of their reference products and they often face challenges related to market acceptance, pricing and regulatory requirements. However, the growing acceptance of biosimilars in the U.S. market can provide a promising outlook.
Short-term impacts might be limited due to the ongoing Phase III clinical trials and subsequent regulatory approval process. However, long-term, the successful commercialization of ADL018 could significantly benefit both companies by capturing a share of the multibillion-dollar market for omalizumab, contributing to revenue diversification, especially for Amneal as it expands beyond oncology.
From a medical research perspective, the licensing agreement for the biosimilar ADL018, which targets free IgE, holds clinical significance for several chronic conditions, including severe persistent allergic asthma, CRSwNP, food allergies and chronic spontaneous urticaria. The ongoing Phase III clinical trial will be important in determining the biosimilar's efficacy and safety compared to XOLAIR®.
For patients and healthcare providers, the introduction of a biosimilar could offer a more cost-effective alternative to XOLAIR®. This is particularly relevant in chronic conditions that require long-term treatment, potentially improving patient access and adherence to therapy. Moreover, with the increasing financial burden of biologic therapies, a successful biosimilar could drive cost savings in the healthcare system.
However, it is essential to consider potential challenges in patient and provider acceptance of biosimilars versus original biologics. Education around the equivalency and safety of biosimilars will be key to achieving a successful market entry.
The move to commercialize a biosimilar to XOLAIR® indicates a strategic expansion for both Kashiv BioSciences and Amneal Pharmaceuticals. By partnering on ADL018, they are venturing into a high-value therapeutic area beyond oncology. The estimated
Biosimilars typically face less price erosion compared to traditional generics due to their complex manufacturing process and clinical trial requirements. Thus, the financial margins on biosimilars can be more favorable. The success of previous biosimilar products by these companies suggests they are well-positioned to navigate the regulatory and market landscapes.
In the long term, the diversification into areas such as allergic asthma and chronic urticaria can help stabilize and grow revenue streams, reducing reliance on any single therapeutic category. This strategic breadth can also protect against market volatility in individual sectors.
Nevertheless, competition in the biosimilar market is intensifying and sustained investment in marketing and education will be necessary to establish a strong foothold.
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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View source 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
Source: Kashiv BioSciences, LLC
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