Health Canada Approves Celltrion's Stoboclo and Osenvelt: A Strategic Move in the High-Growth Denosumab Biosimilars Market

Health Canada's approval of Celltrion's Stoboclo® and Osenvelt® (CT-P41) as denosumab biosimilars in September 2025 marks a pivotal moment in Canada's biosimilars sector. These products, referencing Amgen's Prolia® and Xgeva®, respectively, are now available for all indications, including osteoporosis, bone metastases, and hypercalcemia of malignancy Health Canada approves Celltrion’s Stoboclo® and Osenvelt® (CT-P41) denosumab biosimilars for the treatment of all indications approved for the reference products, Prolia® and Xgeva® respectively^[1]. This approval, supported by robust Phase III clinical evidence demonstrating equivalence in efficacy, safety, and pharmacokinetics to the reference product Celltrion presents additional data from phase III randomized controlled trials to further support biosimilarity for CT-P41 (biosimilar candidate of denosumab) and CT-P47 (biosimilar candidate of tocilizumab) at American College of Rheumatology (ACR) Convergence 2024^[2], positions Celltrion as a key player in a rapidly expanding market. However, the company's competitive positioning must be evaluated against an increasingly crowded landscape, where pricing strategies, regulatory dynamics, and adoption trends will determine long-term success.

Market Entry and Clinical Validation

Celltrion's CT-P41 biosimilars are its sixth approval in Canada, reflecting the company's established expertise in biosimilar development. The Phase III trial (NCT04757376) in postmenopausal women with osteoporosis demonstrated sustained efficacy and safety, even during transitions from reference denosumab to CT-P41 Health Canada approves Celltrion’s Stoboclo® and Osenvelt®(CT-P41), denosumab biosimilars for the treatment of all indications approved for the reference products, Prolia and Xgeva respectively^[3]. This clinical rigor aligns with global regulatory standards and strengthens Celltrion's credibility. Notably, the U.S. FDA approved CT-P41 in March 2025, with a commercial launch in June 2025 following a patent settlement with Amgen FDA Approves Celltrion’s Denosumab Biosimilars, to Launch in June^[4]. The Canadian approval, occurring just months later, suggests a coordinated global market entry strategy.

Competitive Landscape: Pricing and Market Share Projections

The Canadian denosumab biosimilars market is already competitive, with Sandoz's Jubbonti® and Wyost® (approved in March 2024) and Samsung Bioepis's Ospomyv® and Xbryk® (approved in February 2025) as early entrants Biosimilar Cases to Watch: Prolia/Xgeva and Denosumab Competitors^[5]. Sandoz's products, the first interchangeable biosimilars in the U.S., offer a 14.5% and 7% lower wholesale acquisition cost (WAC) compared to Prolia and Xgeva, respectively Sandoz Launches First Interchangeable Denosumab Biosimilars at Discounted WACs^[6]. Celltrion's U.S. pricing strategy—5% lower than reference products—positions it as a mid-tier competitor, balancing affordability with brand trust Celltrion USA announces U.S. launch of denosumab biosimilars, Stoboclo and Osenvelt (denosumab-bmwo)^[7].

In Canada, biosimilars historically capture market shares ranging from 0.9% to 94.5% for certain molecules, driven by cost savings and policy incentives Update on biosimilars in Canada – March 2024^[8]. While no specific pricing data for CT-P41 in Canada is yet available, Celltrion's co-pay assistance programs (e.g., allowing eligible patients to pay as little as $0 per dose) could accelerate adoption STOBOCLO® | Official Site (denosumab biosimilar)^[9]. However, Sandoz's interchangeable designation and Samsung Bioepis's provisional interchangeability may provide a regulatory edge, enabling automatic pharmacist substitution and faster market penetration Two More Pairs of Denosumab Biosimilars Enter US Market^[10].

Adoption Trends and Policy Drivers

Canada's biosimilar market is maturing, with policies increasingly favoring biosimilar use to reduce healthcare costs. For instance, biosimilars of filgrastim and pegfilgrastim have captured 94.5% and 99.9% of the market, respectively Canada’s evolving market for biosimilars and what it means for …^[11]. In the denosumab space, the high unmet need for cost-effective treatments—Amgen's Prolia and Xgeva have seen over 20 price increases since approval—creates a strong tailwind for biosimilars Prolia® / Xgeva® (denosumab) Biosimilar Updates: Celltrion Biosimilar Approval^[12].

Celltrion's experience in the U.S. open market (30% of the denosumab segment) and its prior success with Vegzelma (6% market share in the open market by 2024) suggest a replicable model for Canada Celltrion Launches Stoboclo-Osenvelt in U.S. Osteoporosis Market^[13]. However, Sandoz's early market entry and partnerships with pharmacy benefit managers (PBMs) may give it a first-mover advantage in formulary inclusion and patient access.

Risks and Opportunities

The primary risk for Celltrion lies in the aggressive competition from Sandoz and Samsung Bioepis, as well as pending entries from Fresenius Kabi and others Twelve Potential Competitors and Counting: An Update …^[14]. Litigation settlements, such as Celltrion's agreement with Amgen, mitigate some legal risks but may limit exclusivity periods. Additionally, biosimilar adoption in Canada remains uneven across provinces, requiring tailored commercial strategies.

Conversely, opportunities abound. The global denosumab market, valued at $3.8 billion, is projected to grow as biosimilars drive down prices and expand access Denosumab Market Report 2025-2029 & 2034: Strategic Collaborations and Digital Health Pave the Way for Innovations^[15]. Celltrion's global partnerships (e.g., with Lotus and Intas in Asia) and its focus on patient support programs could differentiate it in markets where affordability and trust are critical Eye on Pharma: Teva, Formycon, Celltrion Biosimilar Updates in …^[16].

Conclusion

Health Canada's approval of Celltrion's CT-P41 biosimilars is a strategic win, leveraging clinical robustness and global regulatory momentum. While Sandoz and Samsung Bioepis hold early advantages in pricing and interchangeability, Celltrion's competitive pricing, co-pay programs, and proven commercialization expertise position it to capture a meaningful share of the Canadian market. Investors should monitor adoption rates, formulary decisions, and the impact of pending biosimilar launches to gauge long-term success. In a sector where cost savings and patient access are paramount, Celltrion's entry underscores the transformative potential of biosimilars in high-growth therapeutic areas.