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Review
. 2024 May:149:105626.
doi: 10.1016/j.yrtph.2024.105626. Epub 2024 Apr 16.

Biosimilars production in Africa opportunities & challenges

Affiliations
Review

Biosimilars production in Africa opportunities & challenges

Amany E Abdel-Maged et al. Regul Toxicol Pharmacol. 2024 May.

Abstract

The healthcare systems of African nations heavily rely on importing and repackaging biological medicine. More than 70% of the pharmaceutical products consumed in Africa are imported. The localization of biosimilar production can have a positive impact on the availability and cost of these products by reducing the expenses for African governments and making essential healthcare products more accessible to the population. However, it is evident that the developing countries, particularly African nations, face various obstacles and difficulties in localizing biosimilar production. These challenges encompass development, manufacturing, evaluation, and registration processes. In this review, we will highlight the significant hurdles and achievements encountered during the localization process of biosimilars.

Keywords: Biological products; Biosimilars; Insulin; Monoclonals.

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Conflict of interest statement

Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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