HAMBURG, Germany, BENGALURU, India & SEATTLE—Mid-October saw Evotec SE and Biocon Ltd. announce that Biocon Biologics, a wholly owned subsidiary of Biocon Ltd, and Just–Evotec Biologics, wholly owned by Evotec, had entered into a strategic licensing agreement for an early-stage, preclinical biosimilar asset.
Biocon Biologics will take this biosimilar asset through end-to-end development, IND filing, manufacturing, commercialization and post-regulatory approval under its own label in global markets. Biocon Biologics aims to address the needs of a large patient pool through this differentiated therapy. Through this in-licensing deal, Biocon Biologics has expanded its current therapeutic basket of biosimilars, going beyond diabetes, oncology and immunology.
Just–Evotec Biologics has a unique platform with deep experience in the fields of protein, process and manufacturing sciences, which it has leveraged to develop this complex molecule. Just–Evotec Biologics has received a license fee from Biocon Biologics and will be eligible to receive development, regulatory and commercial milestone payments; however, specific financial details of the licensing transaction have not been disclosed.
“We are excited to enter into this partnership with Biocon Biologics, a multinational company with a strong presence in biosimilars,” said Dr. James N. Thomas, executive vice president and global head of biotherapeutics and president of U.S. operations at Just–Evotec Biologics. “Just–Evotec Biologics’ optimized product and process platform has generated an excellent early-stage product candidate which we have licensed to Biocon Biologics for further development using their late-stage development, manufacturing and commercial capabilities to bring a compelling treatment to patients. We look forward to providing support to the Biocon Biologics team as their program advances towards the clinic.”
Added Dr. Christiane Hamacher, CEO of Biocon Biologics: “We are extremely confident of the quality of the biosimilar asset developed by Just–Evotec Biologics, and this collaboration will provide a head start for Biocon Biologics to commercialize a biosimilar under its own brand. Leveraging our R&D skills and manufacturing expertise, we aim to take this differentiated therapy from ‘bench to bedside.’ This product expands our therapeutic basket and will enable us to address unmet patient needs for a high quality affordable therapy.”
Under the agreement, Biocon Biologics will now assume all development and commercialization responsibilities for the program. Biocon Biologics will benefit from Just–Evotec Biologics’ experience in the process development domain, particularly with respect to optimized manufacturability.
Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz, and many it is developing independently. The company’s therapeutic pipeline includes molecules for diabetes, oncology, immunology, dermatology, ophthalmology, neurology, rheumatology and inflammatory diseases.