11 October 2019 | News
Biocon Biologics will take this biosimilar asset through end-to-end development
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Biocon Limited and Evotec SE have announced that Biocon Biologics, a wholly owned subsidiary of Biocon Ltd, and Just - Evotec Biologics, wholly owned by Evotec, have entered into a strategic licensing agreement for an early-stage, pre-clinical biosimilar asset.
Biocon Biologics will take this biosimilar asset through end-to-end development, IND filing, manufacturing and commercialization 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 an undisclosed license fee from Biocon Biologics and will be eligible to receive development, regulatory and commercial milestone payments.
Dr Christiane Hamacher, CEO, Biocon Biologics, said: “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.”
Dr James N. Thomas, EVP, Global Head Biotherapeutics & President US Operations at Just - Evotec Biologics, said: “We are excited to enter into this partnership with Biocon Biologics, a multinational company with a strong presence in biosimilars. Just – Evotec Biologics’ optimised 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.”
“This is the beginning of a great relationship between Just – Evotec Biologics and Biocon Biologics,” Dr Thomas added.
Under the agreement, Biocon Biologics will now assume all development and commercialization responsibilities for the program. Biocon Biologics will benefit from Just – Evotec Biologics’ vast experience in the process development domain particularly with respect to optimised manufacturability.
R&D is at the core of Biocon Biologics' journey towards meeting its strategic long-term goal of addressing the needs of millions of patients worldwide. Biocon Biologics’ scientific expertise and world class R&D and manufacturing facilities have enabled it to bring multiple biosimilar therapeutics to the US and Europe.
Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz, and is developing many independently. The Company’s therapeutic basket includes molecules from diabetes, oncology, immunology, dermatology, ophthalmology, neurology, rheumatology and inflammatory diseases.
Financial details of the licensing transaction have not been disclosed.