Biosimilar Drugs for Psoriasis: Principles, Present, and Near Future.

Jose-Manuel Carrascosa,Danielle Petersel,Robert Strohal,Ira Jacobs

doi:10.1007/s13555-018-0230-9

Jose-Manuel Carrascosa, Danielle Petersel + Show 2 more

Open Access

https://doi.org/10.1007/s13555-018-0230-9

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Abstract

Psoriasis is a chronic, inflammatory, lifelong disease with a high prevalence (afflicting approximately 1–5% of the population worldwide) and is associated with significant morbidity. The introduction of biologic therapies has improved the management of this disease. Multiple biologic medicines that block cytokine signaling, including tumor necrosis factor (TNF) antagonists (adalimumab, etanercept, and infliximab) and inhibitors of interleukin (IL)-17 (brodalumab, ixekizumab, and secukinumab), IL-23 (guselkumab), or IL-12/23 (ustekinumab), are approved for the treatment of psoriasis. Despite the clinical benefits associated with use of biologics in psoriasis, many patients are not treated with biologic therapy, and access to treatment may be limited for various reasons, such as high treatment costs. Patents for many biologics have expired or will soon expire, and biosimilar versions of these agents are available or in development. A biosimilar is a biological product that is highly similar to an approved biologic (i.e., originator or reference) product, and has no clinically meaningful differences in safety, purity, or potency when compared with the reference product. Biosimilars may offer less expensive treatment options for patients with psoriasis; they also may increase access to and address problems with underutilization of biologic therapy. Biosimilar development and approval follows a well-regulated process in many countries, with guidelines developed by the European Medicines Agency, US Food and Drug Administration, and World Health Organization. Currently, several anti-TNF biosimilars are available for use in patients with psoriasis, and other monoclonal antibodies are in development. This review provides dermatologists and those who treat and/or manage psoriasis with a working knowledge of the scientific principles of biosimilar development and approval. It also examines real-world experience with biosimilars available for or used in dermatology that will enable physicians to make informed treatment decisions for their patients with psoriasis.Funding: Pfizer Inc.

Highlights

Psoriasis is a chronic, inflammatory disease that affects between 1% and 5% of the population worldwide [1]
Biosimilars of infliximab [CT-P13 (Inflectra/Remsima), PF-06438179/GP1111 (Ixifi) and SB2 (Flixabi; Renflexis)] were studied in patients with rheumatoid arthritis (RA) and/or ankylosing spondylitis (AS) in the initial development programs [40, 44, 45, 47, 48, 54, 55], but through extrapolation have been approved by the European Medicines Agency (EMA) or Food and Drug Administration (FDA) for all licensed indications of the originator, excluding those protected by data exclusivity [56, 82,83,84,85,86]
As a lowercost alternative to originator biologic products, biosimilars may generate cost savings that can be reinvested into the development of innovative treatment options for patients with psoriasis

Summary

Introduction

Inflammatory disease that affects between 1% and 5% of the population worldwide [1]. On the basis of the totality of the evidence from analytical and nonclinical studies, a tailored clinical trial program for the potential biosimilar is designed as a final comparative evaluation to confirm that the product has similar efficacy, safety, and immunogenicity to the originator.

Results

Conclusion