Author byline as per print journal: Pritha Paul1, PhD; Rahul Kapur2,*, MBBS, PhD; Shivani Mittra2, MPharm, PhD; Nimish Shah3, JD, MBA; Gopal K Rao1, MSc; Matthew E Erick4, BS, RPh; Susheel Umesh1, BPharm, MBA; Sandeep N Athalye2, MBBS, MD
Abstract: |
Submitted: 1 March 2024; Revised: 25 April 2024; Accepted: 27 April 2024; Published online first: 6 May 2024
Introduction
The burden of non-communicable diseases (NCDs) is increasing rapidly across the globe. NCDs cause nearly 75% of all deaths worldwide, and 85% of the people who die yearly due to NCDs are from low- and middle-income countries (LMIC) [1]. The risk of dying prematurely from NCDs in LMICs is almost twice as high as in high-income countries (HICs) [2]. The Healthcare budgets are more limited, and the regulatory systems, although evolving, are less developed in LMICs compared to those of HICs, which translates to poor access to life-saving medicines. The disparity in access to essential medicines for NCDs is a plausible contributing factor to a higher number of premature deaths from NCDs in LMICs compared to HICs [3]. Biosimilars can help increase patients’ access and affordability to lifesaving biological medicines by promoting pricing competition with the originator biologicals/reference products (RPs). As most of the literature around biosimilars focuses on HICs, this review article offers insights into the challenges faced for biosimilar uptake and offers recommendations for faster and better access to biosimilars in emerging markets and, more broadly, LMICs. Focusing on data from selected emerging markets (Brazil, Colombia, Malaysia, Mexico, Nigeria, Turkey, and Taiwan), we explored trends in the regulatory framework of biosimilars, potential and actual benefits of biosimilars, and challenges in accessing quality-assured biosimilars. Finally, recommendations to enhance access and use of quality-assured biosimilars in LMICs and a list of potential criteria to help stakeholders in LMICs select these quality-assured biosimilars are also provided.
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This manuscript has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record.