Similis Bio Partners With Novel351k to Develop Multiple Biosimilar Programs Targeting Cancer and Autoimmune Diseases
SUNNYVALE, California, February 14, 2023 – JSR Life Sciences, LLC (“JSR”) today announced that Similis Bio (“Similis”), its business unit focused on biosimilar development, has announced plans to enter into a partnership with Novel351k to co-develop three biosimilar programs that address a wide range of hard-to-treat diseases. Under the initial agreement, Similis will be responsible for cell line development, analytics, process development, and cGMP production, leading to pharmacokinetics/pharmacodynamic clinical trials. Novel351k will leverage its experience with regulatory and clinical strategies to accelerate the development of the programs toward commercialization.
“We launched Similis to make a wider selection of biosimilars available to patients, and we look forward to working with the Novel351k team on this important endeavor,” said John Gabrielson, JSR Life Science’s Senior Vice President and Head of Similis Bio. “This unique partnership combines Similis’ broad CMC expertise and Novel351k’s innovative clinical approach, underscoring our goal of accelerating the delivery of life-saving medicines to patients at lower costs.”
The companies anticipate that the partnership will progress to late-stage development activities and commercial manufacturing, pending a successful outcome of early-stage trials. The therapeutics developed under the partnership have a current annual market value exceeding $15B. The co-development agreement has a projected value of $100MM over more than ten years, including development milestones and royalties.
“Novel351k supports the adoption of groundbreaking scientific approaches to reduce redundant testing and to accelerate the development of biosimilars," said Sarfaraz Niazi, Ph.D., Founder and Chief Scientific Officer of Novel351k. “To that end, we aim to create a positive, measurable impact through our development and manufacturing model with world-class partners.”
Keara Sauber, CEO of Novel351k, shares with her team the excitement to push innovative partnership models forward to increase the accessibility of biosimilars globally. “This low-cost, fast-to-market strategy, combined with our CDMO partnerships and deep regulatory experience, is unique to the industry. We look forward to partnering with Similis Bio and JSR to support our goal of improving patients' lives worldwide.”
Novel351k was founded on the principle of building an organization and culture focused on innovation to develop biosimilar drugs by driving the costs of drugs down through the healthcare spectrum. Novel351k’s strategy accelerates drug innovation, development, and commercialization by delivering affordable access to life-changing biologics while improving quality of life to patients. Additionally, Novel351k believes that strategically partnering with Similis Bio and JSR Life Sciences will be the cornerstone to successfully reduce the cost structures for developing biosimilars. Our partnership for the product development pipeline will deliver the next generation of world-class FDA-approved biosimilars. The highly accomplished Novel351k team with 100+ years of combined experience and active involvement with 10+ approved biosimilars has taken the lead for the advocacy of working with the FDA to streamline the regulatory process to shorten the biosimilar approval process.
JSR launched Similis Bio to mitigate the innate barriers to market entry for biosimilars and promote more productive development programs. Similis provides biosimilar drug developers with technology to accelerate development timelines and lower costs. By offering complete analytical and process development packages, Similis supplies companies with data to determine an appropriate biosimilar target and accelerate early program development. Data packages include reference product data, analytical procedures, process expertise, and CMC templates from a centralized model designed to give partners access to higher quality biosimilars at a lower cost than other development models.
A business unit of JSR Corporation, JSR Life Science LLC is changing human health as a strategic partner and pathfinder for the life sciences industry. Rooted in a history of materials innovation, JSR LS provides specialized products, materials, and services to biopharmaceutical companies and academic researchers. Together with its world-class affiliates, JSR LS offers best-in-class integrated services designed to de-risk molecule selection, accelerate development timelines, increase clinical success rates, and develop novel in vitro diagnostics. JSR LS’s global network of affiliates includes Crown Bioscience, KBI Biopharma, Inc., Selexis SA, and MEDICAL & BIOLOGICAL LABORATORIES CO., LTD. The company operates R&D and applications labs, manufacturing facilities, and sales offices worldwide. For more information, visit JSRLifeSciences.com.