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Organon and Samsung Bioepis Expand Agreement to Commercialize PYZCHIVA® (ustekinumab), a Biosimilar Referencing STELARA® (ustekinumab) in Canada
INCHEON, South Korea & KIRKLAND, Quebec, June 18, 2026--Organon and Samsung Bioepis expand agreement to commercialize PYZCHIVA® (ustekinumab), a biosimilar referencing STELARA® (ustekinumab) in Canada
About this update from Organon & Co.
The amended agreement deepens Organon and Samsung Bioepis’s collaboration to six biosimilars in Canada across multiple therapeutic areas, including immunology, oncology and dermatology. To be launched in Canada in 2026 INCHEON, South Korea & KIRKLAND, Quebec, June 18, 2026--(BUSINESS WIRE)--Samsung Bioepis and Organon, a global healthcare company with a deep expertise in biosimilars, announced the expansion of their development and commercialization agreement, whereby Organon will obtain commercialization rights in Canada to PYZCHIVA®, Samsung Bioepis’s biosimilar referencing STELARA® (ustekinumab). PYZCHIVA® is indicated for the treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn’s disease who have had an inadequate response, loss of response to, or were intolerant to either immunomodulators or one or more tumour necrosis factor-alpha (TNFα) antagonists, or have had an inadequate response, intolerance or demonstrated dependence on corticosteroids, moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies. Under the terms of the agreement, Organon will obtain exclusive commercial rights to the product in Canada while Samsung Bioepis will maintain full development, manufacturing, and regulatory responsibilities. This agreement expands the biosimilar portfolio under Organon and Samsung Bioepis’s collaboration in Canada from five to six complementary products. The five other products in the collaboration in Canada are HADLIMA® (adalimumab), BRENZYS® (etanercept), RENFLEXIS® (infliximab), AYBINTIO® (bevacizumab), and ONTRUZANT® (trastuzumab). PYZCHIVA® is expected to be launched in the market in 2026. "In Canada, biosimilars have played a significant role in strengthening the financial stability of the healthcare systems by reducing medical expenditure for the governments, hospitals, and patients. Samsung Bioepis is proud to have contributed to making biologic medicines more affordable for all stakeholders. By expanding our commercial partnership with Organon, we hope to create greater synergy in accelerating access to our biologic medicines,&...