Organon and Samsung Bioepis add ustekinumab biosimilar to Canada deal

Organon and Samsung Bioepis have expanded their commercialization agreement in Canada to include PYZCHIVA (ustekinumab), a biosimilar referencing Johnson & Johnson's STELARA, with a planned launch in 2026.

Under the amended terms, Organon will hold exclusive commercial rights to PYZCHIVA in Canada, while Samsung Bioepis retains full development, manufacturing, and regulatory responsibilities. The addition brings the total number of biosimilars covered under the two companies' Canadian collaboration from five to six.

The five existing products in the partnership are HADLIMA (adalimumab), BRENZYS (etanercept), RENFLEXIS (infliximab), AYBINTIO (bevacizumab), and ONTRUZANT (trastuzumab), spanning immunology, oncology, and dermatology.

PYZCHIVA is indicated in Canada for adult patients with chronic moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn's disease, and moderately to severely active ulcerative colitis, in cases meeting specific clinical criteria.

"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 at Samsung Bioepis.

Organon (NYSE: OGN) is headquartered in Jersey City, New Jersey, with a Canadian office in Kirkland, Quebec. Samsung Bioepis is a wholly owned subsidiary of Samsung Epis Holdings, established in 2012 and based in Incheon, South Korea. The information in this article is based on a press release issued by the two companies.

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