Kashiv BioSciences has announced an exclusive licensing agreement with Amneal Pharmaceuticals for ADL018, a proposed biosimilar to omalizumab, referencing XOLAIR®, for the United States market. This agreement aims to expand access to a more affordable treatment option for conditions currently addressed by omalizumab.
Omalizumab is a humanized monoclonal antibody that targets free IgE. It is administered via injection and prescribed for several chronic conditions, including severe persistent allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), food allergies, and chronic spontaneous urticaria. The reference product, XOLAIR®, is typically administered in a hospital or clinic setting.
ADL018: A Biosimilar in Phase III Development
ADL018, developed by Kashiv BioSciences, is currently undergoing Phase III clinical trials, which commenced in the third quarter of 2023. The biosimilar is designed to offer a cost-effective alternative to omalizumab, potentially increasing patient access to this important therapy.
"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..." said Dr. Sandeep Gupta, Chief Executive Officer of Kashiv.
Market Context and Potential Impact
According to IQVIA®, U.S. annual sales for XOLAIR® were approximately $3.2 billion for the 12 months ending April 2024. The introduction of a biosimilar like ADL018 could significantly alter the market landscape by providing a lower-cost alternative, potentially driving down healthcare costs and improving patient access.
"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 at Amneal.
