What is the primary objective of the partnership between Samsung Bioepis and Organon (NYSE:OGN) regarding PYZCHIVA®?

The companies have expanded their agreement to grant Organon exclusive commercial rights to PYZCHIVA® in Canada, aiming to increase patient access to affordable biosimilar treatments. This initiative is designed to help reduce medical expenditures for governments, hospitals, and patients while supporting a sustainable healthcare system.

Which specific medical conditions will PYZCHIVA® be used to treat?

PYZCHIVA® (ustekinumab) is indicated for adult patients with chronic moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn’s disease or ulcerative colitis. It serves as an alternative for patients who have had an inadequate response or intolerance to conventional therapies or other biologics.

What are the respective roles of Samsung Bioepis and Organon (NYSE:OGN) under this agreement?

Organon (NYSE:OGN) holds exclusive commercial rights to market and distribute the product in Canada. Meanwhile, Samsung Bioepis retains full responsibility for the development, manufacturing, and regulatory duties associated with the biosimilar.

When is PYZCHIVA® expected to be available in the Canadian market?

The companies have announced that PYZCHIVA® is expected to be launched in the Canadian market in 2026.

How does this expansion impact the broader portfolio managed by the two companies?

This move increases the number of complementary biosimilar products under the collaboration in Canada from five to six. The existing portfolio already includes HADLIMA®, BRENZYS®, RENFLEXIS®, AYBINTIO®, and ONTRUZANT®.

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Organon and Samsung Bioepis expand biosimilar partnership

Written by Mahathir BayenaPublished Jun 18, 2026, 10:07 AM

Organon (NYSE:OGN) has secured exclusive Canadian commercialization rights for PYZCHIVA®, a biosimilar to STELARA® (ustekinumab), from Samsung Bioepis.
The addition of PYZCHIVA® brings the total number of biosimilar products in the companies’ Canadian collaboration to six.
The partners aim to leverage this expanded portfolio to increase patient access to affordable biologic treatments and support the sustainability of the Canadian healthcare system.

Samsung Bioepis and Organon (NYSE:OGN) have announced an expansion of their long-standing partnership, granting Organon exclusive commercialization rights in Canada for PYZCHIVA® (ustekinumab), a biosimilar referencing the biologic STELARA®.

This agreement builds upon a decade-long collaboration, growing the shared portfolio of biosimilars available in the Canadian market from five products to six.

"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.

Under the new terms, Samsung Bioepis will retain full responsibility for the development, manufacturing, and regulatory processes of PYZCHIVA®, which is currently expected to launch in the Canadian market in 2026.

The companies expect that this addition will provide a cost-effective alternative for patients managing conditions like inflammatory bowel disease (IBD) and psoriasis, helping to reduce overall expenditure for the Canadian healthcare system.

Following the announcement of the expanded agreement, Organon's share price was unchanged at $15.82.

The collaboration's existing Canadian portfolio includes five other established products: HADLIMA® (adalimumab), BRENZYS® (etanercept), RENFLEXIS® (infliximab), AYBINTIO® (bevacizumab), and ONTRUZANT® (trastuzumab).

Organon and Samsung Bioepis expand biosimilar partnership

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