Samsung Bioepis NL B.V.

Pictured: Novartis headquarters in Basel, Switzerland/iStock, Kannan D Sandoz on Monday signed a development and commercialization contract with Samsung Bioepis for SB17, the latter’s biosimilar to Johnson & Johnson’s Stelara (ustekinumab). As the Novartis division nears its spin-off, Sandoz will have exclusive rights to commercialize the biosimilar in the U.S., Canada, Switzerland, U.K. and European Economic Area. Financial terms of the Sandoz-Samsung Bioepsis agreement remain confidential, according to Monday’s announcement. The deal with Samsung Bioepis “will further strengthen our immunology patient offering and means we now have five potential high-value upcoming biosimilar launches over the next few years,” Sandoz CEO Richard Saynor said in a statement. This list includes its two in-house assets: GP2411, a biosimilar for Amgen’s osteoporosis therapy Prolia (denosumab) and SOK583A1, which mimics Bayer’s blockbuster eye injection Eylea (aflibercept). Sandoz has also partnered with other companies—such as Bio-Thera Solutions, Polpharma Biologics and Biocon—to further deepen its pipeline. Monday’s commercialization deal will also help Sandoz become a “standalone global leader” in the generics and biosimilars space, according to the announcement. The contract comes as Sandoz is preparing to spin off into its own separate entity next month. Last week, its parent company Novartis confirmed the spin-off, pending final approval from its shareholders. The Swiss pharma group will hold an extraordinary general meeting on Sept. 15 to secure the go-ahead. Novartis finalized its plans to spin off Sandoz in August 2022. At the time, a company spokesperson told BioSpace that the move would allow both businesses to maximize value for their shareholders. Nearly a year later, in July 2023, the company’s board unanimously endorsed the spin-off. Stelara, the reference treatment for SB17, is a monoclonal antibody that works by binding IL-12 and IL-23. It was first approved by the FDA in September 2009 for the treatment of severe plaque psoriasis. It has since picked up nods in other inflammatory diseases, including Crohn’s disease and ulcerative colitis. Patent protections over one of the molecules used in Stelara’s formulation will expire on Sept. 25. Several other would-be competitors are already waiting for this impending loss of exclusivity. Amgen is leading the pack and under a May 2023 settlement, its biosimilar can enter the U.S. market no later than Jan. 1, 2025, subject to the FDA’s approval. A month later, J&J also settled with Teva and Alvotech, granting the partners’ biosimilar entry into the U.S. no later than Feb. 1, 2025. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Enters into a commercialization agreement for SB17, ustekinumab biosimilar candidate, in Europe and North America Partnership to support Samsung Bioepis pipeline expansion and provide increased access to biosimilars INCHEON, Korea, Sept. 11, 2023 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that it has entered into a commercialization agreement with Sandoz for SB17, a proposed biosimilar to Stelarai (ustekinumab), marking a step forward in strengthening access to Samsung Bioepis’ immunology portfolio in the United States (US), Canada, European Economic Area (EEA), Switzerland and United Kingdom (UK). “This agreement is a testament to Samsung Bioepis’ strong track record in the field of immunology, demonstrating a potential value that our biosimilars could deliver for widening access to biologic medicines.” said Sang-Jin Pak, Executive Vice President and Head of Commercial Division, at Samsung Bioepis. SB17, a proposed biosimilar to Stelara (ustekinumab), is Samsung Bioepis’ fourth candidate in its immunology pipeline, following SB4 (etanercept), SB2 (infliximab) and SB5 (adalimumab). Samsung Bioepis has a more than 5-year track record of supplying over 48 million units of immunology biosimilars in nearly 40 markets across the world. In March, the company presented Phase 1 clinical study results of SB17 at the 2023 American Academy of Dermatology (AAD) Annual Meeting, which demonstrated pharmacokinetics (PK) equivalence and comparable safety, tolerability, immunogenicity profiles between SB17 and reference ustekinumab. SB17 Phase 3 clinical study results are set to be presented at a medical congress this year as Phase 3 study was completed in December 2022. About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology and endocrinology. For more information, please visit: and follow us on social media – Twitter, LinkedIn. i Stelara is a trademark of Janssen Pharmaceuticals. MEDIA CONTACT Jane Chung: ejane.chung@samsung.com Anna Nayun Kim, nayun86.kim@samsung.com