2022
DOI: 10.2147/btt.s376959
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Biosimilars: Science, Implications, and Potential Outlooks in the Middle East and Africa

Abstract: Biosimilars are biological products that efficiently replicate the function of the originator products. They have changed the prognosis of millions of patients with many serious conditions. The main engine beyond their development is to bring competition into the marketplace, accordingly further the healthcare systems’ sustainability. Furthermore, by lowering financial obstacles to biological treatments, biosimilars play a critical role in budgetary redistribution and, hence, promote better allocation of scarc… Show more

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Cited by 6 publications
(9 citation statements)
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“…The approval of biosimilars is based on the totality of the evidence that demonstrates a high degree of similarity with the reference product following a rigorous comparative testing process [ 13 , 26 , 42 ]. Therefore, rheumatologists must understand the available evidence in order to confidently counsel patients regarding biosimilars as a viable and more affordable treatment option for rheumatic diseases [ 12 ].…”
Section: Overarching Principles and Consensus Recommendationsmentioning
confidence: 99%
See 2 more Smart Citations
“…The approval of biosimilars is based on the totality of the evidence that demonstrates a high degree of similarity with the reference product following a rigorous comparative testing process [ 13 , 26 , 42 ]. Therefore, rheumatologists must understand the available evidence in order to confidently counsel patients regarding biosimilars as a viable and more affordable treatment option for rheumatic diseases [ 12 ].…”
Section: Overarching Principles and Consensus Recommendationsmentioning
confidence: 99%
“…The approval processes for biosimilars mandate a high level of similarity in the physiochemical characterization and clinical outcomes to that of reference products [ 12 , 13 , 42 ]. Although biosimilars are expected to remain highly comparable to their reference products over time, it is critical to gather real-world post-marketing efficacy and safety data in order to track clinical outcomes [ 12 , 31 , 44 ].…”
Section: Overarching Principles and Consensus Recommendationsmentioning
confidence: 99%
See 1 more Smart Citation
“…Other parties are also independently organising themselves. For instance, in late 2019, a workshop on biologics and biosimilars in Nairobi, Kenya, brought together officials from business and roughly 15 national regulatory agencies from across Africa for training and the exchange of concepts and solutions to regional regulations 23…”
Section: Current Efforts To Make Biosimilars In Africa Availablementioning
confidence: 99%
“…WHO recommends that governments should simplify registration procedures, take into account tax exemptions or reductions, and perhaps regulate markups in the distribution chain (involving wholesalers, distributors and retailers). In addition, WHO recommends increasing the awareness of biosimilars among healthcare professionals (HCPs), combining pricing systems to provide a preferential and competitive environment, and fostering agreements and partnerships with reputable biotech industries 23 24…”
Section: Biosimilars In Africa: Light At the End Of The Tunnel: The W...mentioning
confidence: 99%