Biosimilars in chronic inflammatory diseases: facts and remaining questions 5 years after their introduction in Europe

ABSTRACT

Introduction

Five years after the launch of the first infliximab biosimilar, biologics have found their place in the treatment of chronic inflammatory conditions, but there are remaining questions. This is a review of the introduction of antibody biosimilars in Europe; the reasons for their success and how biosimilar hesitancy was quailed.

Areas covered

We provide an overview of the concepts of biosimilarity, extrapolation, and interchangeability, using examples in rheumatology and gastroenterology for illustration. A review of the evidence collected from switching studies using robust designs is included. Remaining questions such as ‘inter-switching’ are also discussed.

Expert opinion

Biosimilars have democratized access to powerful medicines. Efficacy and safety studies provided reassuring data, but knowledge gaps persist. The availability of so-called ‘bio-betters’ might open new avenues and change clinical practice.

KEYWORDS:

• Access
• adalimumab
• antibodies
• anti-inflammatory
• biosimilars
• Europe
• immunogenicity
• infliximab
• switch

Article highlights

• The benefits of biosimilars go beyond their economic impact. Data show changes in clinical practice as well,

• A large body of evidence exists now, with data on efficacy, safety, switch, and to some extent immunogenicity,

• Originator drugs and biosimilars represent different versions of the same drug,

• Even though interchangeability among biosimilars remains an open question, data accumulated so far do not point toward any safety concern,

• The sustainability of a biosimilar market is largely dependent on regulatory requirements but also on their adoption by practitioners,

• Biosimilars have influenced the way pharmaceutical companies are developing new drugs, leading to more innovation.

Declaration of interest

C Agboton is an employee of Takeda Pharmaceuticals. He worked at Hospira/Pfizer during the launch phase of Inflectra ®(CT-P13). He also served as medical director for the immunology biosimilar portfolio of Sandoz. J Salameh is an employee of Alnylam Pharmaceuticals. He worked at Hospira/Pfizer during the launch phase of Inflectra® (CT-P13), and at Biogen during the launch of Benepali® (SB-4) and Flixabi® (SB-2). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

One of the peer reviewers on this manuscript has been a coordinator and organizer of the Latin American Forum on Biosimilars. They also gave lectures and have produced some educational material for Pfizer, Amgen, Sandoz, Fresenius Kabi, Celltrion, Janssen, and AbbVie. A second peer reviewer on this manuscript declares to have received research, speaking, and/or consulting support from Arcutis, Dermavant, Galderma, GSK/Stiefel, Almirall, Alvotech, Leo Pharma, BMS, Boehringer Ingelheim, Mylan, Celgene, Pfizer, Ortho Dermatology, AbbVie, Samsung, Janssen, Lilly, Menlo, Merck, Novartis, Regeneron, Sanofi, Novan, Qurient, National Biological Corporation, Caremark, Advance Medical, Sun Pharma, Helsinn, Arena, Forte, Informa, UpToDate, and National Psoriasis Foundation. They also consult for others through Guidepoint Global, Gerson Lehrman, and other consulting organizations. They are also a founder and majority owner of www.DrScore.com, and a founder and part owner of Causa Research, a company dedicated to enhancing patients’ adherence to treatment. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper is not funded.