Amneal Adds Omalizumab, Expanding Biosimilars to Eight

Amneal Pharmaceuticals Inc. (Nasdaq: AMRX) has announced the inclusion of omalizumab, which references XOLAIR®, into its biosimilar development portfolio. Omalizumab is a humanized monoclonal antibody that targets free immunoglobulin E (IgE) and is used as an injectable prescription medication. The drug is indicated for multiple chronic conditions including severe persistent allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), food allergies, and chronic spontaneous urticaria. Typically administered in hospital or clinic settings, this biosimilar was developed by Kashiv BioSciences, LLC and has entered a Phase III clinical trial that began in the third quarter of 2023.

Amneal's Vice President of Biosimilars and Branded Oncology, Sean McGowan, expressed enthusiasm over the new development, highlighting the company's commitment to broadening its biosimilar offerings beyond oncology. This addition aligns with Amneal's mission to provide affordable biologic medicines, thereby enhancing accessibility and choice for both patients and healthcare providers. McGowan emphasized that the introduction of omalizumab will contribute to cost savings in the U.S. healthcare system.

Dr. Sandeep Gupta, Chief Executive Officer of Kashiv BioSciences, also shared his optimism about the partnership with Amneal. Dr. Gupta noted that ADL018, the proposed biosimilar to XOLAIR®, is Kashiv's most advanced product in their pipeline. He pointed out the successful collaboration with Amneal on biosimilars such as RELEUKO® and FYLNETRA®, and the progress in additional peg-filgrastim programs. According to Dr. Gupta, Kashiv is one of the few U.S.-based companies to manufacture and secure marketing authorization for multiple biosimilars. By maintaining a focus on quality and cost-effective development, Kashiv aims to continue its track record of delivering high-quality, affordable biosimilars to improve patient lives globally.

IQVIA® data indicates that U.S. annual sales for XOLAIR® reached approximately $3.2 billion for the 12 months ending April 2024. XOLAIR® is a registered trademark of Novartis AG.

Although the financial terms of the transaction were not disclosed, Amneal has accounted for any incremental expenses related to these products within its financial guidance.

Amneal Pharmaceuticals, Inc., headquartered in Bridgewater, NJ, is a global pharmaceutical company focused on the development, manufacturing, and distribution of over 280 pharmaceutical products, primarily in the United States. The company operates through three segments: Generics, Specialty, and AvKARE. The Generics segment is extensive, covering a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. The Specialty segment focuses on branded pharmaceuticals for central nervous system and endocrine disorders, with a pipeline aimed at unmet medical needs. The AvKARE segment serves as a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets.

Amneal continues to focus on expanding its portfolio and developing new products to meet diverse medical needs while emphasizing affordability and accessibility.