Biosimilars demonstrate **comparable efficacy and safety to originator biologics** for moderate-to-severe psoriasis while offering substantially lower costs, creating significant potential to expand treatment access in low- and middle-income countries where price barriers currently restrict patients' access to effective treatments.[1][2][5] **Clinical Equivalence Confirmed** A systematic review of 14 randomized clinical trials and 3 cohort studies found no clinically or statistically significant differences in efficacy and safety between biosimilars and their originator products for psoriasis treatment.[5] Specific comparisons—including biosimilar MSB11022 (adalimumab) and CT-P13 (infliximab)—showed similar reductions in Psoriasis Area and Severity Index scores and comparable adverse event rates.[1] Twenty-four biosimilars derived from 4 reference products are now approved for psoriasis treatment in the United States.[6] **Addressing Access Barriers** Although biologic therapies have significantly improved psoriasis outcomes, their high costs have limited access and created healthcare inequalities, particularly in resource-limited regions.[2] Biosimilars promise to improve patient access to these proven effective treatments while maintaining improved health outcomes and reducing overall treatment costs.[2] **Important Considerations and Limitations** Evidence quality varies across settings. Most clinical evidence derives from randomized controlled trials; high-quality real-world effectiveness data across diverse healthcare systems remains limited.[5] Biosimilars can receive regulatory approval for psoriasis based on extrapolated evidence from other diseases rather than direct psoriasis trials.[5] Long-term safety and immunogenicity data are limited compared to originators due to their shorter market presence.[1] Additionally, patent protections continue to restrict biosimilar availability in some regions.[3] While switching from originator to biosimilar appears safe based on available evidence, careful patient monitoring during transitions remains important.[2]
Originaltitel: The role of biosimilars in enhancing global access to psoriasis treatment