Organon and Samsung Bioepis Expand Agreement to Commercialize PYZCHIVA® (ustekinumab), a Biosimilar Referencing STELARA® (ustekinumab) in Canada
The amended agreement deepens Organon and Samsung Bioepis's collaboration to six biosimilars in Canada across multiple therapeutic areas, including immunology, oncology and dermatology.
To be launched in Canada in 2026
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).
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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
For more information about PYZCHIVA® (ustekinumab) in Canada, including important safety information, visit https://www.organon.com/canada-en/wp-content/uploads/sites/5/2026/06/PYZCHIVA_PM-EN.pdf.
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. As a wholly owned subsidiary of Samsung Epis Holdings, Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, endocrinology. For more information, please visit www.samsungbioepis.com and follow us on LinkedIn and X.
About Organon
Organon is an independent global healthcare company dedicated to improving the health of women throughout their lives. With a diverse portfolio of over 70 medicines and products in women's health, biosimilars, and general medicines across a range of therapeutic areas, Organon is committed to innovation and collaboration. Headquartered in Jersey City, New Jersey, with a Canadian office in Kirkland, Quebec, Organon has approximately 10,000 employees worldwide.
For more information, visit www.organon.ca and connect with us on LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States' Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about PYZCHIVA® for the treatment of adult patients with chronic moderate to severe plaque psoriasis and other conditions, as well as statements regarding the expanded commercial launch of that product and other biosimilars in Canada pursuant to the development and commercialization agreement. Forward-looking statements may be identified by words such as "will," "expected," and words of similar meaning. These statements are based upon the current beliefs and expectations of Organon's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon's filings with the U.S. Securities and Exchange Commission ("SEC"), including Organon's most recent Annual Report on Form 10-K and other SEC filings, available at the SEC's Internet site (www.sec.gov). Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
STELARA® is a trademark registered in Canada in the name of Johnson & Johnson. Organon is not associated with this trademark owner.
i Crohn's and Colitis Canada. Resources and Publications. Available at: https://crohnsandcolitis.ca/About-Us/Resources-Publications/Impact-of-IBD-Report. Accessed on June 12, 2026.
ii Canadian Dermatology Association. Psoriasis. Available at: https://dermatology.ca/public-patients/skin/psoriasis/. Accessed on June 12, 2026.
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Organon Canada Media Contact:
media_canada@organon.com
Organon Investor Relations:
Jennifer Halchak (201) 275-2711
Samsung Bioepis Media Contacts:
Yoon Kim, yoon1.kim@samsung.com
Anna Nayun Kim, nayun86.kim@samsung.com