Kashiv Biosciences

Kashiv Biosciences, LLC is a fully integrated biopharmaceutical company focused on developing biosimilars and specialty biopharmaceutical products. The company has global research and development, clinical, regulatory, and manufacturing capabilities. Kashiv utilizes its MayaBio reactor technology to develop biosimilars. The company's product portfolio includes biosimilars targeting conditions such as asthma, chronic idiopathic urticaria, and neutropenia. Kashiv's lead biosimilar candidate, ADL018, is a proposed biosimilar to Xolair (omalizumab) currently in Phase III clinical trials for chronic spontaneous urticaria. In March 2022, Kashiv received FDA approval for its first biosimilar RELEUKO (filgrastim-ayow), a biosimilar referencing Neupogen. The company has a robust pipeline of seven biosimilars and multiple 505(b)(2) and complex peptide generic products in development. Kashiv operates FDA-approved GMP manufacturing facilities in Chicago, Illinois and has state-of-the-art R&D infrastructure in Ahmedabad, India. The company is headquartered in Piscataway, New Jersey.

Key customers and partnerships

Kashiv has established strategic partnerships to commercialize its products globally. In October 2023, Kashiv entered into an exclusive licensing agreement with Alvotech for the development and commercialization of ADL018 in Europe, the UK, Australia, Canada, and New Zealand. In July 2024, Kashiv signed an exclusive licensing agreement with Amneal Pharmaceuticals for the commercialization of ADL018 in the US. Kashiv has also collaborated with Amneal on the development and commercialization of other biosimilars, including RELEUKO and FYLNETRA. These partnerships allow Kashiv to leverage its partners' commercial expertise and global reach to bring its biosimilar products to market.