On February 15, 2023 JSR Life Sciences, LLC ("JSR") reported 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 (Press release, JSR, FEB 15, 2023, View Source [SID1234627213]). 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.
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"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."