Samsung Bioepis and Organon have expanded their development and commercialization agreement to include PYZCHIVA (ustekinumab), a biosimilar referencing STELARA (ustekinumab), with Organon obtaining commercialization rights in Canada. PYZCHIVA is expected to launch in the Canadian market in 2026 and will become the sixth biosimilar covered under the companies’ collaboration in the country, alongside HADLIMA (adalimumab), BRENZYS (etanercept), RENFLEXIS (infliximab), AYBINTIO (bevacizumab), and ONTRUZANT (trastuzumab).
Under the amended agreement, Organon will hold exclusive commercial rights to PYZCHIVA in Canada, while Samsung Bioepis will retain responsibility for development, manufacturing, and regulatory activities. PYZCHIVA is indicated for 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 in patients with inadequate response, loss of response or intolerance to immunomodulators, TNFα antagonists or corticosteroids, and moderately to severely active ulcerative colitis in patients with inadequate response, loss of response, intolerance or contraindications to conventional therapy or biologics.
Executives from both companies said biosimilars have played an important role in helping strengthen the financial stability of Canada’s healthcare systems by reducing medical expenditures for governments, hospitals, and patients, and noted that the expanded collaboration aims to further support access to biologic treatments and provide additional options for clinicians and patients.
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