Biosimilars for Psoriasis: Worldwide Overview of Regulatory Guidelines, Uptake and Implications for Dermatology Clinical Practice

Abstract

The introduction of biologic drugs for the treatment of patients with psoriasis has revolutionized treatment paradigms and enabled numerous patients to achieve disease control with an acceptable safety profile. However, the high cost of biologics limits access to these medications for the majority of patients worldwide. In recent years, the introduction of biosimilars for inflammatory diseases has become a fast evolving field. The future use of biosimilars offers the potential for decreased cost and increased access to biologic drugs for patients with psoriasis. For their approval, different regulatory agencies use highly variable methods for definition, production, approval, marketing, and post-marketing surveillance of biosimilars. Due to potential interchangeability between biologics and biosimilars, traceability and pharmacovigilance are required to collect accurate data about adverse events in psoriasis patients; spontaneous reporting, registries, and use of "big data" should facilitate this process on a global basis. The current article describes biosimilar regulatory guidelines and examples of biosimilar uptake in clinical practice in several countries around the world. As it is apparent that biologic treatment decisions may become more physician-independent, the International Psoriasis Council recommends that dermatologists should take an active role in the development of biosimilar prescribing policies with their respective healthcare settings and governmental agencies.

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