Biosimilar’s Growth in Pharmerging Markets: An Analysis of the Regulatory Environments

Abstract

The introduction of biosimilars to health care markets across the globe has had some success in increasing competition and improving the cost of healthcare. While savings are important for driving the biosimilar uptake, this is not the only consideration for the growth of biosimilars onto emerging markets. A systematic review of the literature to assess the growth of biosimilars onto the emerging market was conducted using the following data sources: PubMed, Website of the Generics and Biosimilars Initiative (GaBI) journal, ProQuest, Google Scholar. Studies that provided evidence of biosimilars onto the emerging market through surveys and other sources of existing data were included. The systematic review process followed Wichor et al. (2018) and the PRISMA checklist (PRISMA, 2009). The search strategy for the review provided a total of 71studies, which underwent title, abstract and full text review to give 20 articles that fit the inclusion criteria for the aimed study. A quality assessment was conducted on the 20 articles and by using the Hawker et al. (2002) quality tool and directed research questions to set variables, the data analysis of 13 articles emerged. The included studies agreed on the growth of biosimilars onto the emerging market and on the switch to biosimilars to improve access to therapies. However, International Nonproprietary Name (INN) and physician confidence were still considered as hurdles. The two most successful drivers of the growth of biosimilars onto the emerging market based on this review was certainly the regulation of the process followed by the cost of biosimilars. To conclude, data analysis of 13 articles determined that the general perception of using biosimilars in emerging markets is positive. However, for successful integration into routine healthcare and uptake into these markets, there must be a direct focus on the regulation of Biosimilars