The global landscape on interchangeability of biosimilars

ABSTRACT

Introduction

Biosimilars hold the potential to be an integral healthcare component that can significantly improve affordability and thereby accessibility of the otherwise expensive biotherapeutic products. Regulators, payors, and policymakers, each have a major role to play in successful adoption of biosimilars. One of the issues that has been a point of frequent discussion is that of interchangeability of biosimilars.

Areas covered

This article aims to review the position that the major regulatory bodies have taken on interchangeability of biosimilars. Key issues that remain are also discussed. Adalimumab and etanercept have been chosen as real-world case studies to demonstrate interchangeability considerations. The need for gaining global harmonization on interchangeability is highlighted.

Expert Opinion

A global harmonization on the interchangeability can likely accelerate biosimilar adoption and result in better accessibility to biologics. Experience gained with real-world studies supports switching to biosimilars from originators however post-marketing pharmacovigilance should be in place to assess the risk-benefit profile of biosimilars in the long run.

KEYWORDS:

• Adalimumab
• biosimilar
• etanercept
• interchangeability
• switching

Article highlights

• Perspectives of different regulatory bodies on biosimilar interchangeability have been reviewed.

• The effect of switching to biosimilars on safety and immunogenicity profile has been discussed.

• Two case studies, adalimumab and etanercept, have been presented to demonstrate interchangeability considerations.

This box summarizes key points contained in the article.

Declaration of interest

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

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Supplementary material

Supplemental data for this article can be accessed here

Additional information

Funding

This work was funded by the Department of Biotechnology, Ministry of Science and Technology (BT/COE/34/SP15097/2015).