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The Goeckerman Regimen for the Treatment of Moderate to Severe Psoriasis
Published on: July 11, 2013
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Biosimilars in psoriasis: what should your positioning be?
Ricardo Ruiz-Villaverde1, Manuel Galán-Gutierrez2
1Instituto de Investigación Biosanitaria ibs, Hospital Universitario San Cecilio , Granada, Spain.
Expert Opinion on Biological Therapy
|July 21, 2020
Summary
Biosimilars have improved access to psoriasis treatments, but their positioning requires review. Clinical decisions for biosimilars should balance efficacy and economics, not solely rely on cost-effectiveness.
Area of Science:
- Dermatology
- Pharmacoeconomics
- Drug Development
Background:
- Biosimilars have significantly enhanced patient access to biological treatments for psoriasis, primarily driven by economic advantages.
- Assessing the current market positioning and clinical integration of biosimilars is crucial for optimizing psoriasis management.
Purpose of the Study:
- To evaluate the current positioning of biosimilars in psoriasis therapy.
- To analyze accessibility, regulatory approval, and clinical practice variations for biosimilars globally.
Main Methods:
- A comprehensive bibliographic review was conducted.
- Data sources included drug technical sheets, regulatory guidelines, and clinical practice data (2015-2020) from PubMed® and Embase®.
- Analysis focused on accessibility, switching/interchangeability criteria, and regulatory landscapes.
Main Results:
- Biosimilar accessibility varies significantly across countries, irrespective of FDA or EMA standards, due to local regulatory requirements.
- Switching, interchangeability, and substitution criteria for biosimilars are inconsistent, with outcomes ranging from clinical trial data to non-binding recommendations.
- Biosimilars are deemed appropriate for a substantial patient population.
Conclusions:
- The clinical utility of biosimilars in psoriasis is established, but their role as first-line therapy requires careful consideration against traditional systemic drugs and novel anti-IL agents.
- Clinical decision-making for biosimilars must integrate efficacy and safety data alongside economic factors, rather than prioritizing cost alone.
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