Similis Bio Partners With Novel351k to Develop Multiple Biosimilar Programs Targeting Cancer and Autoimmune Diseases
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
MarkLines Gen-AI Beta Version Released for Automotive Industry13.1.2026 02:00:00 EET | Press release
MarkLines Co., Ltd. (Headquarters: Minato-ku, Tokyo; President & CEO: Makoto Sakai; TYO:3901) announced its launch of the "MarkLines Gen-AI Beta Version," the new feature for B2B users in the automotive industry. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260112383839/en/ "MarkLines Gen-AI Beta Version" can take questions in natural language and instantly give highly reliable, relevant data drawn from MarkLines’ extensive automotive database (Image: MarkLines Co., Ltd.) This AI-powered feature enables users to ask questions in natural language and instantly receive highly reliable, relevant data drawn from MarkLines’ extensive automotive database. Moreover, the system analyzes this information by leveraging the rich content across its platform and delivers clear, concise, text-based insights. By combining trusted data with advanced analytical capabilities through generative AI, this service represents a first-of-its-kind
Australian Defence Force Secures Satellite Communications on SES IS-2212.1.2026 23:30:00 EET | Press release
Satellite communications solutions provider SES will provide secure uninterrupted satellite communications to the Australian Defence Force (ADF) for a minimum of 16 years thanks to a new extended agreement. The service will be provided via the SES Intelsat 22 satellite and an ultra-high frequency (UHF) military communications payload. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260112137182/en/ Assistant Secretary Space Systems Branch, Michael Hunt, formalizes contract negotiations for the through-life support of the IS-22 satellite with Rory Welch, senior vice-president of service delivery at SES Space and Defense. Photos: Corporal Annika Smit Under the renewed arrangement, SES will reposition the IS-22 satellite to a new orbital slot specified by the ADF, continuing a mission that has been the cornerstone of Australia’s secure military communications since IS-22’s launch in 2012. SES will build a dedicated ground segmen
NetApp Appoints Paul Fipps to the Board of Directors12.1.2026 23:05:00 EET | Press release
NetApp® (NASDAQ: NTAP), the intelligent data infrastructure company, today announced that Paul Fipps, President of Global Customer Operations at ServiceNow, has joined its Board of Directors. The board now has ten directors, nine of whom are independent, and 50% of whom have been appointed within the last five years. Fipps brings more than 20 years of experience driving technology-enabled growth and customer transformation. At ServiceNow, he currently leads global sales, customer success, partner ecosystems, and field operations. He previously served as EVP of Worldwide Sales at ServiceNow and as President of Under Armour Connected Fitness and Chief Experience Officer at Under Armour, overseeing global direct-to-consumer, connected fitness, and digital experiences. He also previously served on the advisory board of Quantum Metric. Fipps holds a B.S. in Information Systems, an MBA from the University of Baltimore, and is a graduate of The Wharton School’s Advanced Management Program. “P
FDA Accepts New Drug Application for Pimicotinib for the Treatment of Tenosynovial Giant Cell Tumor12.1.2026 21:00:00 EET | Press release
Merck, a leading science and technology company, announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s new drug application (NDA) for pimicotinib as a systemic treatment for patients with tenosynovial giant cell tumor (TGCT). The application is based on the primary results and longer-term follow-up of the global Phase 3 MANEUVER study, which demonstrated deep and durable tumor responses and meaningful improvements in clinical outcomes with pimicotinib. “With pimicotinib, we have an opportunity to significantly advance care for people living with TGCT, a painful and debilitating disease that has few effective and well-tolerated treatment options beyond surgery,” said David Weinreich, Global Head of R&D and Chief Medical Officer for the Healthcare business of Merck. “Based on clinical trial results showing not only a reduction in tumor burden, but also the ability to help alleviate symptoms like pain and stiffness in the global Phase 3 MANEUVER study
Fabentech receives Marketing Authorization for Ricimed®, an antidote against ricin poisoning12.1.2026 20:32:00 EET | Press release
Fabentech, a French biopharmaceutical company specializing in medical countermeasures against biological threats, today announces that it has been granted Marketing Authorization for Ricimed®, a treatment for ricin poisoning. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260112241557/en/ Ricimed - Fabentech Ricimed®, an antidote against one of the most toxic natural substances in the world In addition to supportive care, and in severe situations requiring immediate administration, Ricimed® represents a new therapeutic option for the management of acute ricin intoxication. Ricin, among the most dangerous naturally occurring substances, can cause death within hours or days regardless of the route of exposure, making it a major biological threat for many countries. Having demonstrated its ability to specifically target and neutralize ricin before irreversible damage occurs, Ricimed® is an antibody-based therapy relying on poly
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