Increasing adoption of quality-assured biosimilars to address access challenges in low- and middle-income countries

Category: Review Article
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Keywords: affordability, biosimilars, low- and middle-income countries (LMICs), market access, non-communicable diseases, regulatory framework

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

Non-communicable diseases (NCDs) disproportionately affect people living in low- and middle-income countries (LMICs) compared to high-income countries (HICs). Given the particularly limited healthcare resources in LMICs, increasing the adoption of biosimilar products can be a viable solution to expand access to medicines. Biosimilars can allow patients to be treated with more affordable biological products compared to their originator biologicals. As most of the literature around biosimilars focuses on HICs, this review article offers insights into the benefits of biosimilars for better access to biologicals in LMICs, focusing on data from selected emerging markets. Insights were mainly gathered via conducting interviews in LMICs on exploring challenges towards access to biosimilars and were supplemented with a literature search. This review article highlights the burden of non-communicable diseases (NCDs) in LMICs, trends in the regulatory space for biosimilars, benefits of biosimilars, and challenges in accessing biosimilars in emerging markets. The challenges include weaker regulatory frameworks, dependence on importation, low awareness of biosimilars, and the need for effective policies encouraging access to and use of biosimilars. This review article suggests recommendations to increase access to and adoption of quality-assured biosimilars in LMICs, including strengthening regulatory and pharmacovigilance systems, providing guidance on prescribing biosimilars and education on biosimilars, strengthening national policies to increase adoption of biosimilars, encouraging local manufacturing, and encouraging stakeholders’ initiatives promoting access to biosimilars. Acknowledging that affordability remains a main factor for stakeholders’ purchasing decisions, this paper offers additional criteria beyond price that may help stakeholders in LMICs select quality-assured biosimilars.

Submitted: 1 March 2024; Revised: 25 April 2024; Accepted: 27 April 2024; Published online first: 6 May 2024


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. 

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