Samsung Bioepis and Organon Expand Canadian Biosimilar Portfolio with PYZCHIVA

Samsung Bioepis and Organon have expanded their commercialization partnership in Canada to include PYZCHIVA® (ustekinumab), Samsung Bioepis’ biosimilar referencing STELARA®. Under the amended agreement, Organon will obtain exclusive commercialization rights for the product in Canada, while Samsung Bioepis will retain responsibility for development, manufacturing, and regulatory activities. Commercial launch is anticipated in 2026.

The agreement strengthens a long-standing collaboration between the two companies and expands their Canadian biosimilar portfolio from five to six products. The existing partnership already includes HADLIMA® (adalimumab), BRENZYS® (etanercept), RENFLEXIS® (infliximab), AYBINTIO® (bevacizumab), and ONTRUZANT® (trastuzumab), spanning immunology and oncology indications.

Expanding Access to Ustekinumab Therapy

PYZCHIVA is a monoclonal antibody biosimilar of ustekinumab, an interleukin (IL)-12 and IL-23 inhibitor widely used to treat chronic immune-mediated inflammatory diseases. The therapy is indicated for adults with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic treatment, active psoriatic arthritis, moderately-to-severely active Crohn’s disease, and moderately-to-severely active ulcerative colitis.

By blocking IL-12 and IL-23 signaling pathways, ustekinumab helps control inflammation that drives these chronic conditions. Like other biosimilars approved in Canada, PYZCHIVA must demonstrate high similarity to its reference biologic under Health Canada’s biosimilar regulatory framework, including comparable efficacy, safety, and quality standards.

Addressing a Significant Disease Burden

Inflammatory bowel disease (IBD) remains a major health challenge in Canada. Estimates suggest that approximately one in 140 Canadians lives with Crohn’s disease or ulcerative colitis, both of which cause chronic intestinal inflammation and can significantly affect quality of life.

Psoriasis also affects a substantial patient population, with roughly one million Canadians living with the chronic inflammatory skin disease. Up to 30% of individuals with psoriasis develop psoriatic arthritis, a progressive condition that can lead to joint damage and disability if left untreated.

By lowering biologic drug costs, biosimilars such as PYZCHIVA may reduce financial barriers for patients requiring long-term treatment while supporting broader access to advanced therapies.

Strategic Growth for Biosimilars in Canada

Jinhan Chung, Vice President and Head of Commercial Strategy for International Markets at Samsung Bioepis, said the expanded partnership reflects the growing role of biosimilars in improving affordability and strengthening healthcare system sustainability. He noted that the collaboration with Organon is expected to accelerate access to biologic medicines in Canada while helping ensure a reliable supply of ustekinumab biosimilars for patients.

Dominic Bégin, President and Managing Director of Organon Canada, highlighted the companies’ long-standing collaboration and Organon’s decade of experience in the Canadian biosimilar market. He said the addition of PYZCHIVA creates an opportunity to expand patient access to an important treatment option while supporting healthcare providers and contributing to a more sustainable healthcare system.

Path Forward

The addition of PYZCHIVA further strengthens one of the largest biosimilar collaborations in Canada and expands treatment options across immunology and oncology. With six biosimilars now included in the partnership and a planned 2026 launch, the alliance strengthens both companies’ presence in Canada’s growing biosimilar market while reinforcing the expanding role of biosimilars in improving treatment access and healthcare sustainability.

 Reference

Samsung Bioepis and Organon Expand Agreement to Commercialize PYZCHIVA® (ustekinumab), a Biosimilar Referencing STELARA® (ustekinumab) in Canada