Anti-TNF biosimilars in rheumatology: the end of an era?

ABSTRACT

Introduction

Tumor necrosis factor inhibitors (TNFi) have revolutionized the treatment of rheumatic diseases. Whilst extremely efficacious, the original TNFi also carried a high acquisition cost that limited their use. ‘Biosimilar’ TNFi’s, developed on expiry of the patents for the biooriginators, have comparable efficacy and safety, are less expensive and provide the potential to improve access to these effective therapies in a more cost-effective manner.

Areas covered

The background and development of TNFis, their biosimilars and follow on ‘copycat’ drugs are discussed, together with their use in both developed and developing countries, focusing on the potential to enhance access to effective targeted therapies.

Expert opinion

Bridging the economic gap to facilitate universal access to anti-TNF biosimilars has been largely unsuccessful, driving the development of copycat mimics in developing countries. Meanwhile, the more recent introduction of targeted synthetic disease-modifying drugs has provided cheaper, equally effective treatments for rheumatic diseases that are conveniently delivered by mouth.

We review the TNF biosimilars in rheumatic diseases, their role in a rapidly evolving treatment landscape, and speculate about the future for this iconic therapeutic class.

KEYWORDS:

• Biologic
• rheumatoid arthritis
• TNF inhibitor
• inflammation
• therapy
• biosimilar

Article highlights

• TNF inhibitor drugs have proven revolutionary in the treatment of rheumatic diseases, including rheumatoid arthritis and axial spondyloarthropathies, but remain relatively expensive.

• The subsequent introduction of biosimilar TNFi with similar efficacy and safety to the originator drugs have driven down acquisition costs and provide the potential to widen access to these medications.

• Despite a generally favorable response to TNF biosimilars, significant barriers to widespread use remain, including perceived concerns about safety and tolerability and a lack of patient (and sometimes physician) awareness, which may outweigh the potential cost-saving of biosimilar-use.

• The demand for low cost targeted therapies in developing countries has spawned the production of ‘copycat’ or ‘mimic’ biologics, which are released into the market without the detailed safety and clinical testing that is required for the development of TNF biosimilars.

• In more recent years, the treatment landscape in rheumatic diseases has evolved yet further, with the arrival of small molecule targeted-synthetic disease-modifying anti-rheumatic drugs (tsDMARDs), such as the JAK inhibitors, with comparable efficacy and safety to anti-TNF drugs.

• The relative failure of widespread adoption of TNF biosimilars, despite their lower acquisition cost, combined with the introduction conveniently administered oral tsDMARDs, should lead us to consider the future role of TNF biosimilars in the rapidly changing treatment landscape in rheumatic diseases.

This box summarizes key points contained in the article.

Declaration of interest

RJ Moots has received research grants, consultancy, and/or sponsorship for participation in speaker meetings for: AbbVie, AKL pharma, Amgen, Chugai, Eli Lilly, Gilead, Novartis, Pfizer, Roche, UCB Pharma. 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 reviewers has served over many years as an ad hoc consultant to pharma companies making originator biologics and in the last two years to Celltrion, Biogen, and Fresenius Kabi (manufacturers of biosimilar anti-TNFs). Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper is not funded.