Introduction
Risankizumab-rzaa, marketed as Skyrizi, is a monoclonal antibody developed by AbbVie and Boehringer Ingelheim for the treatment of various autoimmune diseases. This article delves into the market dynamics and financial trajectory of Skyrizi, highlighting its impact on the pharmaceutical industry, particularly in the context of biosimilar competition and product hopping strategies.
Background on Skyrizi
Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis (PsA), and moderate to severe active Crohn’s disease (CD) in adult patients[4].
Clinical Efficacy
Clinical trials have demonstrated the superior efficacy of Skyrizi over its predecessor, Humira (adalimumab). A head-to-head phase 3 clinical trial showed that more patients achieved 90% improved skin on Skyrizi compared to Humira (72% vs 47%)[1]. Additionally, Skyrizi demonstrated significant improvements in psoriatic arthritis symptoms, including ACR20, ACR50, and ACR70 responses, as well as improvements in dactylitis and enthesitis[2].
Market Performance
Skyrizi has rapidly gained traction in the market, surpassing Humira as AbbVie’s top-selling drug. In the third quarter of 2024, Skyrizi saw a 50.8% global increase in revenues to $3.205 billion, while Humira’s global revenues fell by 37.2% to $2.227 billion[1].
Product Hopping and Its Impact
The strategy of "product hopping" has been instrumental in Skyrizi's success. This involves shifting demand from an innovator drug facing generic or biosimilar competition to new, patented versions. AbbVie has effectively moved patients from Humira to Skyrizi and another drug, Rinvoq, to mitigate the impact of biosimilar competition on Humira sales[1].
Consequences for Biosimilars
Despite the growing fill volume for adalimumab biosimilars, the total adalimumab market volume has decreased significantly due to the increased adoption of Skyrizi and Rinvoq. This trend raises concerns about the sustainability of the adalimumab biosimilar market, as biosimilars are now competing for a smaller market share[1].
Financial Trajectory
AbbVie’s financial reports reflect the significant impact of Skyrizi on the company’s revenue. The immunology portfolio, which includes Humira, Skyrizi, and Rinvoq, contributed $7.046 billion in the third quarter of 2024, with Skyrizi and Rinvoq driving the growth. Skyrizi’s global revenues have more than doubled, while Humira’s revenues have declined sharply[1].
Revenue Breakdown
- Skyrizi: $3.205 billion, up 50.8% globally.
- Humira: $2.227 billion, down 37.2% globally.
- Rinvoq: $1.614 billion, up 45.3% globally[1].
Market Indications and Expansions
Skyrizi has received approvals for multiple indications, including plaque psoriasis, psoriatic arthritis, and Crohn’s disease. The FDA approval for psoriatic arthritis was based on data from the KEEPsAKE-1 and KEEPsAKE-2 studies, which showed significant improvements in ACR20, ACR50, and ACR70 responses compared to placebo[2].
Future Indications
There are forecasts and ongoing studies for additional indications such as ulcerative colitis, with high probabilities of approval in the U.S., EU, and Japan[3].
Competitive Landscape
The competitive landscape in the biologic market is highly dynamic, with companies like AbbVie employing strategies to maintain market dominance. The shift from Humira to Skyrizi and Rinvoq has allowed AbbVie to retain a significant market share despite the entry of biosimilars.
Industry Expert Insights
Nick Adolph, principal of US market access strategy at IQVIA Institute for Human Data Science, noted that the strategy of moving patients to new products has significantly reduced the total adalimumab market size, making it challenging for biosimilars to gain substantial traction[1].
Patient and Market Impact
The superior efficacy and safety profile of Skyrizi have led to high patient satisfaction and retention rates. For example, in a follow-up phase of a clinical trial, 66% of adalimumab responders who switched to risankizumab maintained high skin clearance, compared to 21% who continued adalimumab[1].
Patient Outcomes
Clinical trials have consistently shown that Skyrizi offers better outcomes for patients with plaque psoriasis and psoriatic arthritis. The drug has demonstrated improvements in skin lesions, dactylitis, and enthesitis, enhancing the quality of life for patients[2][5].
Regulatory and Approval Process
Skyrizi has received regulatory approvals from the U.S. FDA for its various indications. The approvals are supported by robust clinical data from studies like KEEPsAKE-1 and KEEPsAKE-2, which evaluated the efficacy and safety of Skyrizi in patients with psoriatic arthritis[2].
Conclusion
The market dynamics and financial trajectory of Skyrizi highlight the drug's significant impact on the biologic market. Through effective product hopping strategies, AbbVie has managed to maintain its market dominance despite the entry of biosimilars. Skyrizi's superior efficacy and safety profile have made it a preferred choice for patients and healthcare providers, driving its rapid growth and financial success.
Key Takeaways
- Market Leadership: Skyrizi has surpassed Humira as AbbVie’s top-selling drug.
- Product Hopping: The strategy has significantly reduced the adalimumab market size, impacting biosimilar adoption.
- Clinical Efficacy: Skyrizi has shown superior efficacy over Humira in clinical trials.
- Financial Performance: Skyrizi’s revenues have more than doubled, contributing significantly to AbbVie’s immunology portfolio.
- Regulatory Approvals: Skyrizi has received FDA approvals for multiple indications, including psoriatic arthritis and Crohn’s disease.
FAQs
What is Skyrizi used for?
Skyrizi (risankizumab-rzaa) is used for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis (PsA), and moderate to severe active Crohn’s disease (CD) in adult patients[4].
How has Skyrizi impacted the adalimumab biosimilar market?
The growth of Skyrizi has led to a decrease in the total adalimumab market volume, making it challenging for biosimilars to gain substantial traction despite their increasing fill volume[1].
What is product hopping, and how has it affected Skyrizi’s success?
Product hopping involves shifting demand from an innovator drug to new, patented versions. This strategy has allowed AbbVie to move patients from Humira to Skyrizi and Rinvoq, mitigating the impact of biosimilar competition on Humira sales[1].
What are the key clinical trial findings for Skyrizi?
Clinical trials have shown that Skyrizi is superior to Humira in achieving 90% skin clearance for psoriasis patients and has significant improvements in psoriatic arthritis symptoms, including ACR20, ACR50, and ACR70 responses[1][2].
What are the future indications for Skyrizi?
There are forecasts and ongoing studies for additional indications such as ulcerative colitis, with high probabilities of approval in the U.S., EU, and Japan[3].
Sources
- Center for Biosimilars: Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar Market in Limbo.
- PR Newswire: U.S. FDA Approves Second Indication for SKYRIZI® (risankizumab-rzaa) to Treat Adults with Active Psoriatic Arthritis.
- Clarivate: Potential blockbusters make a splash on market entry.
- Clinical Trials Arena: Skyrizi (risankizumab-rzaa) treatment of plaque psoriasis, USA.
- Molina Healthcare: Skyrizi (risankizumab-rzaa) - Coverage Criteria.
Last updated: 2024-12-17
