Similis Bio Partners With Novel351k to Develop Multiple Biosimilar Programs Targeting Cancer and Autoimmune Diseases
14.2.2023 15:00:00 EET | Business Wire | Press release
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.”
About Novel351k
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.
About Similis Bio
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.
About JSR Life Sciences, LLC
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230214005036/en/
Contact information
JSR Life Sciences/Similis Bio
Missy Bindseil
JSR Life Sciences Company Inquiries
Director, Marketing & Communications
mbindseil@jsr-nahq.com
Laura Morgan
JSR Life Sciences Media Inquiries
Sam Brown Inc.
lauramorgan@sambrown.com
(951) 333-9110
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Red Sea Global Strengthens AMAALA's Wellness Offering With Opening of Six Senses AMAALA8.7.2026 18:22:00 EEST | Press release
Red Sea Global (RSG), the regenerative tourism developer, has announced the opening of beachfront resort Six Senses AMAALA, which will welcome its first guests mid-July. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260708505794/en/ An aerial view of Six Senses AMAALA and its surrounding shoreline at Triple Bay The launch represents an exciting next step in the AMAALA destination’s journey, as it continues to come to life and welcome guests to enjoy unrivaled wellness experiences set against a backdrop of soaring coastal cliffs, protected bays, pristine beaches, and mountainous desert. "Every partner we bring into our portfolio is selected because they share our long-term vision of luxury travel with regeneration for people and planet at its center. Six Senses has built a global reputation for wellness experiences rooted in nature, sustainability, and local culture, making it a natural fit for AMAALA. As the second Six Sens
Rigaku Opens "Rigaku Solutions Center Osaka" to Strengthen Global Semiconductor Metrology Service Capabilities8.7.2026 18:00:00 EEST | Press release
Rigaku Corporation, a global solution partner in X-ray analytical systems and a group company of Rigaku Holdings Corporation (headquarters: Akishima, Tokyo; CEO: Jun Kawakami; “Rigaku”), has opened the Rigaku Solutions Center Osaka (RSC-Osaka) at its Osaka Plant. The new facility centralizes and expands practical training for field service engineers supporting semiconductor metrology systems, strengthening Rigaku's global service capabilities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260708402770/en/ Photo: Hands-on training using the TXRF-V310 at RSC-Osaka As semiconductor manufacturing processes continue to advance toward finer geometries, higher layer counts, and more complex three-dimensional structures, semiconductor metrology systems require ever greater precision and operational stability. X-ray analytical technologies play an increasingly important role in meeting these demands through highly accurate, non-dest
Dryad Networks Reaches XPRIZE Wildfire Finals Milestone, Demonstrating Autonomous Detection and Suppression of Wildfires in Alaska8.7.2026 18:00:00 EEST | Press release
Dryad Networks, the leader in ultra-early wildfire detection technology, today announced a major achievement in the finals of the Autonomous Wildfire Response track of XPRIZE Wildfire, a four-year, $11 million global competition accelerating new solutions to end destructive wildfires. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707802818/en/ The Silvaguard Suppression Drone can deliver a 100 liter liquid suppressant to autonomously suppress small wildfires detected by Silvanet Competing against just two other finalists selected from an original field of nearly 300 teams worldwide, Dryad successfully demonstrated the integrated capabilities of its Silvanet wildfire detection network and Silvaguard autonomous firefighting drone system during final testing in remote Alaska. The XPRIZE Wildfire finals challenged teams to autonomously detect and suppress a wildfire without any human intervention across a vast 1,000 square k
Cardiac Dimensions ® Announces Three Major Publications Demonstrating Long-Term Durability, Real-World Performance, and Broad Patient Benefit of the Carillon Mitral Contour System ®8.7.2026 17:05:00 EEST | Press release
Cardiac Dimensions, a leader in transcatheter therapies for heart failure, today announced the publication of three major manuscripts that together form the most comprehensive evidence base ever assembled for transcatheter indirect mitral annuloplasty. These publications span a five-year multi-center commercial registry, the largest single-center experience across both preserved and reduced ejection fraction, and long-term survival results through ten years. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707656796/en/ Carillon Mitral Contour System® The Carillon Mitral Contour System is the only commercially available indirect mitral annuloplasty device, designed to treat a broad and expanding population of patients living with functional mitral regurgitation. The newly published data further strengthen the clinical foundation for the therapy as Cardiac Dimensions advances toward regulatory submissions in the United State
First Randomized Controlled Trial Shows Promise of a Ketogenic Diet in Psychotic Disorders8.7.2026 16:00:00 EEST | Press release
Published today in Schizophrenia Bulletin, a first-of-its-kind randomized controlled trial (RCT) from researchers at the University of California, San Francisco (UCSF), and funded in part by the National Institute of Mental Health (NIMH), adds to growing literature on the potential benefit of a ketogenic diet for treating psychotic disorders. The study, which enrolled participants with schizophrenia-spectrum or bipolar-1 disorders, demonstrated rapid metabolic improvements with a ketogenic diet compared to diet-as-usual during an initial one-month RCT open-label phase. Furthermore, those who continued with the optional four-month single-arm ketogenic diet extension saw meaningful gains across metabolic, psychiatric, and cognitive measures. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260618626815/en/ First Randomized Controlled Trial Shows Promise of a Ketogenic Diet in Psychotic Disorders Of the 58 participants enrolled,
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom