Amneal expands biosimilar portfolio with omalizumab
Amneal is expanding its portfolio with omalizumab, a proposed biosimilar of Novartis AG’s Xolair.
Omalizumab is a humanized monoclonal antibody that targets free immunoglobulin E. 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, food allergies and chronic spontaneous urticaria. It is typically administered in a hospital or clinic setting.
The biosimilar was developed by Kashiv BioSciences and is in a Phase III clinical trial that began in the third quarter of 2023.
“We are excited to further grow our biosimilar pipeline with the addition of omalizumab and expand into a new therapeutic area beyond oncology," said Sean McGowan, vice president, biosimilars and branded 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.”
[Related: Amneal touts 39 retail, injectable product launches in 2023]
“We are pleased to partner with Amneal 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 and Fulnetra, and advancement of additional peg-filgrastim programs," said Sandeep Gupta, CEO of Kashiv. "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.”
Xolair had a market value of roughly $3.2 million for the 12 months ended April 2024, per IQVIA.
The financial terms of the transaction were undisclosed, and any incremental expenses associated with these products are contemplated within Amneal’s guidance.
[Related: Amneal touts 39 retail, injectable product launches in 2023]