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,” said Jinhan Chung, Vice President and Head of Commercial Strategy for International Markets, Samsung Bioepis. “We will work relentlessly to ensure continued supply of our ustekinumab biosimilar to patients in the Canadian market.”

“We’re proud to strengthen our longstanding relationship with Samsung Bioepis one of Organon’s key global collaborators as we continue to work to help expand access to medicines and advance a more sustainable healthcare system,” said Dominic Bégin, President and Managing Director, Organon Canada. “In Canada, we have built a strong foundation in delivering accessible biosimilars for patients, as demonstrated over the past ten years. By leveraging our capabilities and expertise, we see opportunity to expand access to this treatment, helping more patients receive the care they need while providing an important alternative option that supports both healthcare providers and the broader system.”

With the addition of PYZCHIVA^® to the Samsung Bioepis and Organon portfolio, the companies reinforce their commitment to delivering more treatment options that can help reduce spending pressures on healthcare systems and expand access to medicines for patients.

An estimated 1 in 140 Canadians lives with Crohn’s or colitis, the two main forms of inflammatory bowel disease (IBD), which cause inflammation of the intestines.ⁱ Also, it is estimated that one million Canadians are currently living with psoriasis, a chronic inflammatory skin condition that causes red to violet elevated areas of skin (plaques), usually covered with silvery-white scales that can be itchy and painful. Up to 30% of patients with psoriasis have associated psoriatic arthritis.ⁱⁱ