Abstract
ABSTRACT Introduction Globally, biosimilars are expected to play a key role in lowering healthcare costs and providing increased patient access to biological therapies. Given this, and in line with the European Union and World Health Organization, many emerging nations have adapted and established biosimilar regulatory guidelines. Emerging nations present a lucrative market for biosimilar development and commercialization, yet they also pose unique challenges. A thorough understanding of the unique attributes of emerging markets in relation to biosimilars is needed to promote their successful uptake in low- and middle-income countries. Areas covered This article highlights the opportunities and challenges that emerging markets represent in terms of biosimilar uptake. A comprehensive analysis of biosimilar uptake in European countries, where biosimilars have gained significant market share, was carried out to identify policies that can enhance market penetration in emerging nations. Expert opinion Implementation of pricing and procurement policies, as well as provider and patient confidence in biosimilar efficacy, are key factors in their uptake. Due to the high cost of biosimilar development, incentivizing domestic companies with the biosimilar manufacturing capability to produce these drugs will be helpful in ensuring a sustainable biosimilar market and a steady supply chain.
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