Business Wire

Similis Bio Partners With Novel351k to Develop Multiple Biosimilar Programs Targeting Cancer and Autoimmune Diseases

Share

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.

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

SLB Announces First-Quarter 2023 Results Conference Call20.3.2023 20:00:00 EET | Press release

SLB (NYSE: SLB) will hold a conference call on April 21, 2023 to discuss the results for the first quarter ending March 31, 2023. The conference call is scheduled to begin at 9:30 am US Eastern time and a press release regarding the results will be issued at 7:00 am US Eastern time. To access the conference call, listeners should contact the Conference Call Operator at +1 (844) 721-7241 within North America or +1 (409) 207-6955 outside of North America approximately 10 minutes prior to the start of the call and the access code is 8858313. A webcast of the conference call will be broadcast simultaneously at www.slb.com/irwebcast on a listen-only basis. Listeners should log in 15 minutes prior to the start of the call to test their browsers and register for the webcast. Following the end of the conference call, a replay will be available at www.slb.com/irwebcast until May 21, 2023, and can be accessed by dialing +1 (866) 207-1041 within North America or +1 (402) 970-0847 outside of North

Theramex Enters Into an Exclusive Licensing Agreement With Radius Health Inc, to Commercialise ELADYNOS® ▼in the European Economic Area, the United Kingdom, Australia and Brazil20.3.2023 19:28:00 EET | Press release

Theramex, a leading global speciality pharmaceutical company dedicated to women’s health, has entered into an exclusive licensing agreement with Radius Health, Inc., for the rights to commercialise ELADYNOS® (abaloparatide), a novel bone forming agent indicated for the treatment of osteoporosis in postmenopausal women at increased risk of fractures. Theramex will commercialise and distribute ELADYNOS® on an exclusive basis in the European Economic Area, the United Kingdom, Australia and Brazil. “Theramex has again shown its commitment to women and the care and good management of bone health, by adding this important product to our Osteoporosis franchise. We are delighted to be entering into this partnership with Radius, building on our expanding portfolio and aligning missions to reduce fracture risks for many postmenopausal women suffering from osteoporosis.” - Rob Stewart, CEO of Theramex “We are thrilled to have Theramex bring abaloparatide to postmenopausal women in Europe who coul

New Stilla Ruby Chip and naica® system 21 CFR Part 11 compliance enable full automation of digital PCR testing for clinically-oriented applications20.3.2023 18:48:00 EET | Press release

Stilla Technologies, the multiplex digital PCR company, has recently introduced the Ruby Chip, the industry’s first ‘load-and-go’ consumable for digital PCR, optimized for its naica® system. The naica® system, which now supports 21 CFR Part 11 regulatory compliance, is part of a fully-automated sample-to-results workflow – the first of its kind for digital PCR. This platform serves the growing throughput and regulatory requirements of many clinically-oriented applications, such as in cell and gene therapy development and quality control or for liquid biopsy applications for the detection of circulating tumor DNA (ctDNA). With adjustable throughput of up to 96 samples processing capability in under three hours, the Ruby Chip is designed with standard SBS plate spacing compatible with multichannel pipettes for manual loading and can be easily integrated with common liquid handling robots. A key feature of the Ruby Chip is that it comes ready-to-use and preloaded with sealed chambers, ena

FlexTrade Hires Senior Sell-Side OMS Specialist to Drive Growth in EMEA Region20.3.2023 17:30:00 EET | Press release

FlexTrade Systems (@FlexTrade), a global leader in multi-asset order and execution management systems, announces the appointment of Rajiv Shah as Head of Sales in EMEA for its sell-side OEMS, FlexOMS. FlexOMS, the flagship OMS platform within FlexTrade's suite of sell-side solutions, is designed to boost trading efficiency by simplifying the complexities of today's trading workflows. The open-architecture trading solution supports high-touch and low-touch businesses by providing a unified multi-asset platform across cash, program trading, futures & options, ETF, swaps, fixed income, and foreign exchange workflows. In this newly created role, Rajiv will drive FlexTrade's business strategy and growth of the solutions to trading desks within EMEA. Rajiv brings over 30 years of experience in financial technology with a proven track record in designing and executing sales and business growth strategies across the front and middle-office trading space within enterprise-grade software firms.

LambdaTest improves its Selenium automation testing experience with the addition of its AI-powered integrated test intelligence20.3.2023 17:30:00 EET | Press release

LambdaTest, an intelligent omnichannel digital experience testing cloud platform, has announced the addition of advanced AI-powered test intelligence features to its Selenium testing cloud offering. With this latest development, LambdaTest will now enable enterprises with deeper insights into their test execution process and help them better streamline their quality assurance process. LambdaTest has been constantly working on enhancing its Selenium automation testing cloud and the test intelligence feature is the latest addition to the list. Over the last quarter, LambdaTest has added features like support for all Selenium 4 versions, including support for BiDi protocol, enhanced low-latency live streaming of test execution for faster test feedback, and the ability to group tests by tags for better manageability. Just last month, LambdaTest added Selenium tracing that allows users to visualize each command flow and each test error along with its telemetry data. All these features combi

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