Organon and Samsung Bioepis have expanded their development and commercialization agreement to include exclusive rights for Organon to commercialize PYZCHIVA in Canada. PYZCHIVA is a biosimilar referencing STELARA (ustekinumab), developed by Samsung Bioepis, and is expected to launch in the Canadian market in 2026. The expansion deepens the collaboration between the two companies, bringing their portfolio of complementary biosimilars in Canada to six products across immunology, oncology, and dermatology.

Under the terms of the agreement, Organon will hold exclusive commercial rights to the product in Canada, while Samsung Bioepis retains responsibility for development, manufacturing, and regulatory matters. 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, and moderately to severely active ulcerative colitis. Specific indications for Crohn's disease include patients 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. For ulcerative colitis, it includes patients 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.

The expanded portfolio now includes five other products: HADLIMA (adalimumab), BRENZYS (etanercept), RENFLEXIS (infliximab), AYBINTIO (bevacizumab), and ONTRUZANT (trastuzumab). Jinhan Chung, Vice President and Head of Commercial Strategy for International Markets at Samsung Bioepis, stated that the partnership aims to accelerate access to biologic medicines and ensure continued supply to patients.

Dominic Bégin, President and Managing Director of Organon Canada, highlighted the company's ten-year history in delivering accessible biosimilars. He noted that leveraging Organon's capabilities provides an opportunity to expand access to treatment, supporting healthcare providers and the broader system. The collaboration reinforces a commitment to reducing spending pressures on healthcare systems and expanding patient access to medicines.

Collaboration Portfolio

Organon announced the US Food and Drug Administration (FDA) approval of the supplemental Biologics License Application (sBLA) for TOFIDENCE (tocilizumab-bavi) injection, expanding its indications to treat critical conditions. The approval specifically includes adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS). Additionally, it covers hospitalized adult and pediatric patients aged 2 years and older with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Jon Martin, US Commercial Lead, Biosimilars and Established Brands at Organon, stated that the approval addresses critical needs for patients facing CRS, a serious side effect of CAR-T therapies. He noted that biosimilar adoption may help reduce the affordability burden of high-cost brand biologics on the healthcare system. By expanding the use of TOFIDENCE, the company aims to advance its biosimilars portfolio and broaden access to treatment options.

TOFIDENCE is the first approved tocilizumab biosimilar entrant in the US market, launched in May 2024. It is also indicated for the treatment of moderately to severely active rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. Organon acquired the regulatory and commercial rights to TOFIDENCE in the US in 2025, while Bio-Thera Solutions Ltd. retains manufacturing rights for the US market.

The product is available in single-dose vials for further dilution prior to intravenous infusion in the following presentations: 80 mg/4 mL (20 mg/mL), 200 mg/10 mL (20 mg/mL), and 400 mg/20 mL (20 mg/mL). Patients treated with tocilizumab products, including TOFIDENCE, are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis, bacterial, invasive fungal, viral, or other opportunistic infections.

Approved Indications

The FDA approval mandates specific safety monitoring, including the interruption of TOFIDENCE if a serious infection develops until the infection is controlled. Patients should be closely monitored for signs and symptoms of infection during and after treatment.