AbbVie's Skyrizi Secures Key Canadian Reimbursement for Ulcerative Colitis – A Catalyst for Long-Term Growth?

AbbVie's Skyrizi (risankizumab) has secured a pivotal milestone in Canada, with the drug receiving positive reimbursement recommendations from Canada's Drug Agency (CDA-AMC) for the treatment of ulcerative colitis (UC) in November 2025 according to reports. This development, coupled with a signed Letter of Intent (LOI) with the pan-Canadian Pharmaceutical Alliance (pCPA), marks a significant expansion of Skyrizi's access in a market poised for growth. For investors, the question remains: Does this reimbursement approval translate into a meaningful catalyst for AbbVie's long-term revenue trajectory and competitive positioning in inflammatory bowel disease (IBD) therapies?

Reimbursement Terms and Therapeutic Implications

Skyrizi's reimbursement in Canada is conditional, targeting adults with moderately to severely active UC who have failed to respond to conventional therapies, biologics, or JAK inhibitors according to clinical data. The CDA-AMC's recommendation, informed by pivotal trials, mandates that Skyrizi be prescribed by an experienced physician and not used in combination with other advanced therapies. Additionally, cost constraints require the drug to be the least expensive reimbursed advanced therapy for this patient population, and patients must demonstrate a response within 12 weeks to continue treatment according to the CDA-AMC's criteria.

These terms reflect a balance between ensuring therapeutic efficacy and managing healthcare system costs. By limiting combination therapies and requiring rapid response, the reimbursement criteria aim to optimize Skyrizi's use while minimizing unnecessary expenditures. For AbbVie, this structured access model could drive steady adoption among refractory UC patients, a population with limited treatment options.

Market Size Discrepancies and Revenue Potential

The Canadian UC market has been reported with conflicting figures-USD 34.34 million in 2024 versus USD 7.2 billion. Resolving this discrepancy is critical. The USD 7.2 billion figure likely represents the total drug market for UC in Canada, encompassing all therapies, while the USD 34.34 million figure may pertain to a specific segment or a typographical error. Regardless, the market is projected to grow at a compound annual growth rate (CAGR) of 6.8% from 2026 to 2033, reaching USD 12.8 billion by 2033.

Skyrizi's entry into this market is bolstered by its role as an IL-23 inhibitor, a newer class of biologics with demonstrated efficacy in IBD. With public reimbursement now secured, AbbVie can capitalize on Skyrizi's differentiation from older therapies like TNF-alpha inhibitors. However, the lack of explicit pricing terms from the pCPA agreement introduces uncertainty. While the LOI ensures market access, the negotiated price could impact AbbVie's margins. In the U.S., AbbVie offers a savings card for commercial insurance patients, allowing as little as $0 per dose.

Competitive Positioning in IBDs

Skyrizi's approval for UC in Canada follows prior approvals for Crohn's disease, psoriatic arthritis, and plaque psoriasis, solidifying its position as a multi-indication blockbuster. In the IBD space, Skyrizi faces competition from other IL-23 inhibitors like Janssen's Tremfya and Bristol Myers Squibb's Tremfya (same molecule), as well as newer entrants like Takeda's ozanimod. However, Skyrizi's favorable efficacy and safety profile in phase 3 trials according to clinical data, combined with its expanded label in Canada, could strengthen its market share.

The reimbursement approval also enhances AbbVie's competitive edge in a region where public drug plans play a dominant role. By securing pCPA access, AbbVie ensures that Skyrizi is positioned as a first-line advanced therapy for refractory UC patients, a demographic with high unmet needs. This strategic move aligns with broader trends in IBD treatment, where personalized medicine and targeted biologics are increasingly prioritized.

Financial and Strategic Implications

For AbbVie, Skyrizi's Canadian reimbursement represents a revenue catalyst in a high-growth therapeutic area. The global Skyrizi market, driven by IBD and dermatology indications, is projected to expand significantly, fueled by rising autoimmune disease prevalence and adoption of personalized therapies. While exact revenue contributions from the Canadian UC market remain opaque, the drug's inclusion in public plans should boost prescriptions and mitigate payer resistance.

However, AbbVie must navigate challenges, including pricing pressures from pCPA negotiations and potential competition from emerging therapies. The company's ability to maintain Skyrizi's premium pricing while demonstrating cost-effectiveness through real-world evidence will be critical. Additionally, resolving the market size discrepancy is essential for accurate revenue forecasting.

Conclusion

AbbVie's Skyrizi has cleared a significant hurdle with Canadian reimbursement for UC, enhancing its therapeutic footprint and financial potential. The structured access model, supported by clinical evidence and patient advocacy, positions Skyrizi as a key player in the IBD landscape. While uncertainties around pricing and market size persist, the drug's multi-indication profile and growing adoption in advanced markets like Canada underscore its role as a long-term growth driver for AbbVie. For investors, the approval reinforces confidence in AbbVie's ability to navigate regulatory and reimbursement challenges in high-stakes therapeutic areas.