Biosimilar Business Recap: New Ustekinumab Partnership; Similis Bio Biosimilar Programs; Celltrion Japan Launch

In the latest biosimilar business news, Fresenius Kabi announced a global partnership with Formycon for an ustekinumab biosimilar; Similis Bio partners with Novel351K to co-develop 3 biosimilars; and Celltrion Healthcare launched its bevacizumab biosimilar in Japan.

Fresenius Kabi and Formycon Partnership

Fresenius Kabi and Formycon announced that they will be partnering on an ustekinumab biosimilar (FYB202) referencing Stelara.

Ustekinumab products are human monoclonal antibodies that target IL-12 and IL-23 for the treatment of moderate-to-severe plaque psoriasis, Crohn disease, ulcerative colitis, and psoriatic arthritis.

“With the commercialization of the ustekinumab biosimilar we are expanding our product portfolio with another autoimmune disease treatment option…" commented Michael Schönhofen, PhD, Fresenius Kabi’s chief operating officer and member of the Fresenius Kabi Management Board, in a statement. "We welcome the potential of this agreement to build on the strengths of our companies across the value chain from development to commercialization."

The licensing agreement will grant Fresenius Kabi exclusive commercialization rights to FYB202 in key global markets, including Germany as well as parts of the Middle East and Northern Africa Region and Latin America. Formycon will be in charge of development and registration with health authorities. Formycon will also receive upfront and milestone payments contingent on the successful achievement of certain regulatory events.

“We are delighted about the conclusion of the agreement and are looking forward to a successful commercialization of our Ustekinumab biosimilar candidate after approval,” said Nicola Mikulcik, chief business officer at Formycon. "The combination of Formycon’s development expertise and Fresenius Kabi’s global commercial competence offers an excellent basis for providing access to our highly efficacious product to many patients."

Similis Bio, Novel351k Co-development Partnership

Similis Bio, the biosimilar business unit of JSR Life Sciences, has partnered with Novel351k to co-develop 3 biosimilar programs. Similis will be responsible for cell line development, analytics, process development, current Good Manufacturing Practice production, and clinical trials. Novel351k will leverage its experience with regulatory and clinical strategies to streamline biosimilar development.

“This unique partnership combines Similis’ broad [chemistry, manufacturing, and controls] expertise and Novel351k’s innovative clinical approach, underscoring our goal of accelerating the delivery of life-saving medicines to patients at lower costs,” shared John Gabrielson, JSR Life Science’s senior vice president and head of Similis Bio.

The companies did not disclose which biosimilar molecules will be included in the deal. However, they revealed that the current combined annual market value of the therapeutics under development exceeds $15 billion.

“Novel351k supports the adoption of groundbreaking scientific approaches to reduce redundant testing and to accelerate the development of biosimilars….To that end, we aim to create a positive, measurable impact through our development and manufacturing model with world-class partners,” said Sarfaraz Niazi, PhD, founder and chief scientific officer of Novel351k as well as an advisory board member of The Center for Biosimilars^®.

Celltrion Healthcare Japan Launch

Celltrion Healthcare launched Vegzelma, a bevacizumab biosimilar referencing Avastin, on the Japanese market, according to a report from the Korea Herald. Bevacizumab products are used to treat a number of cancers, including colorectal, nonsquamous non–small cell lung cancer, glioblastoma, kidney, cervical, and renal cell carcinoma.

The biosimilar was approved by the Japanese Ministry of Health, Labor and Welfare in September 2022. It was also approved in the United States the same month, and it was granted marketing authorization by the European Medicines Agency in August 2022.