The economics of biosimilars and challenges to biosimilar adoption in low- and middle-income countries

ABSTRACT

Introduction

Biologics have shown marked success over the past decades in disease areas as cancer, immunology and diabetes. However, elevated costs of innovative biologic medicines have led to an inequity in accessibility across the world. While 85% of the world’s population lives in low- and middle- income countries (LMIC), 80% of the sales of monoclonal antibodies are attributed to Western countries, highlighting the pronounced market imbalance.

Areas covered

This perspective paper draws some analogies as well as differences between biosimilars and generics, aims to address the unmet need for treatment with biologics in LMICs by reviewing possible causes, economic and social, of low access, displaying the disparity between LMICs and HIC, and suggets countermeasures for this unmet medical need in LMICs.

Expert opinion

It is up to all stakeholders to capitalize on the opportunity that biosimilars provide, mostly by committing to transparent collaboration, to make biotherapeutics accessible to all, regardless of region or country of residence.

KEYWORDS:

• LMIC
• low- and middle-income countries
• biosimilars
• biologics
• biotherapeutics
• LMICs

Article highlights

• There remains an unmet medical need for biologics in LMICs.

• Biosimilars are presented as a solution for the unmet medical need, although

• Differences between biosimilars vs generic medicines include associated costs, clinical equivalence, patient and physician’s trust and market competition.

• Disparity in access between HICs and LMICs may be growing.

• Improvements can be made through global initiatives, international cooperation and innovation on a national scale.

• All stakeholders need to intensify their commitment to transparent collaboration in the search for solutions that are equitable to all.

Declaration of interest

I Abraham holds equity in Matrix45 LLC, which has been contracted for research, analytics, dissemination, consulting, and training services by Janssen/Johnson&Johnson, Amgen, Novartis, and Roche on the originator side and by Sandoz/Novartis, Coherus Biosciences, Mylan/Viatris/Biocon, Hospira/Pfizer, and Teva on the biosimilars side; with past and current conversations with Merck KGaA, Celltrion, Apobiologix, Apogenix, Fresenius-Kabi, and Spectrum, and serving as quantitative methods editor for JAMA Dermatology (compensated) and editor-in-chief for the Journal of Medical Economics (noncompensated). 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 or other relationships to disclose.

Additional information

Funding

This paper was not funded.