Amneal Expands Biosimilars Portfolio to Eight Products with Addition of Omalizumab Biosimilar

Builds on U.S. biosimilar portfolio of seven products with three commercial and four in pipeline

8th biosimilar expands portfolio into allergy treatments, a new therapeutic area

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the addition of omalizumab, referencing XOLAIR®, to its biosimilar pipeline.

Omalizumab is a humanized monoclonal antibody which targets free immunoglobulin E (IgE). 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. It 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 excited to further grow our biosimilar pipeline 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.

“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 FYLNETRA®, and advancement of additional peg-filgrastim programs. 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.

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 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, the Company 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, the Company 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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