INCHEON, South Korea & KIRKLAND, Quebec - Organon has obtained exclusive commercialization rights in Canada for PYZCHIVA, Samsung Bioepis’s biosimilar referencing Stelara (ustekinumab), according to a press release statement.
The amended agreement expands the collaboration between the two companies to six biosimilars in Canada. PYZCHIVA is expected to launch in the Canadian market in 2026.Organon shares have surged nearly 97% over the past six months, trading at $13.42, just below its 52-week high of $13.49. According to InvestingPro analysis, the stock appears undervalued at current levels, with the platform tracking over a dozen additional key metrics and insights for investors.
PYZCHIVA is indicated for treatment of 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.
Under the agreement terms, Organon will hold exclusive commercial rights to the product in Canada while Samsung Bioepis maintains development, manufacturing, and regulatory responsibilities.
The partnership now includes six products in Canada: HADLIMA (adalimumab), BRENZYS (etanercept), RENFLEXIS (infliximab), AYBINTIO (bevacizumab), ONTRUZANT (trastuzumab), and PYZCHIVA.
An estimated 1 in 140 Canadians lives with Crohn’s or colitis, the two main forms of inflammatory bowel disease. Approximately one million Canadians currently live with psoriasis, with up to 30% of psoriasis patients having associated psoriatic arthritis.
Samsung Bioepis, established in 2012, is a wholly owned subsidiary of Samsung Epis Holdings. Organon is headquartered in Jersey City, New Jersey, with a Canadian office in Kirkland, Quebec, and has approximately 10,000 employees worldwide.
Stelara is a trademark registered in Canada in the name of Johnson & Johnson. Organon is not associated with this trademark owner.
In other recent news, Organon reported its first-quarter financial results, which did not meet Wall Street expectations. The company announced adjusted earnings per share of $0.71, falling short of the anticipated $0.83. Revenue also missed estimates, coming in at $1.46 billion compared to the projected $1.52 billion, marking a 4% decline as reported and a 9% decline excluding foreign exchange impacts from the previous year. The revenue decrease was attributed to unfavorable pricing and product mix, notably a 16% drop in Women’s Health revenue. Nexplanon sales fell 21%, with a significant 28% decline in the U.S. due to decreased physician demand and federal funding uncertainties. Additionally, oral contraceptives Marvelon and Mercilon saw a 36% decrease in demand in China, excluding foreign exchange. Meanwhile, Organon received approval from the U.S. Food and Drug Administration for expanded indications of its biosimilar drug TOFIDENCE. The drug is now approved for treating severe cytokine release syndrome and certain COVID-19 conditions in both adults and pediatric patients aged 2 years and older.
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