Volume 11 Issue 1&2 2022 (Published Jan 24, 2022)

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Pharmacovigilance of Biosimilars in Yemen: Challenges in Poor-Resource Setting

Mahmoud M. Al-Sakkaf, Wafa F. Badulla, Sara A. Alshagga, Adel H. Aldhubhani, Nazeh M. Al-Abd, Mohamed I. Ibrahim



Biosimilars are biological medications that are very analogous to confirmed pose biologics and have been approved for use in patients in certain countries worldwide. These biological materials have definite features, which have further challenges in pharmacovigilance. Nevertheless, the evaluation of efficacy, safety, and post-marketing investigation are fundamentals to recognize, estimate and avoid side effects of chemically synthesized small molecule drugs and biologicals, because the complete safety outline could only be recognized after post-marketing.

In this article, the researchers have tried to provide background about biosimilar pharmacovigilance and have discussed the implications for biosimilar pharmacovigilance in Yemen. Moreover, this article reviews several aspects of biosimilar pharmacovigilance, including traceability, pharmacovigilance system development and highlights some challenges in Biosimilars pharmacovigilance. The availability of biosimilars as lower-cost biologics must wisely consider issues of safety, efficacy, and traceability. Strict pharmacovigilance procedures are needed to evaluate the potential variances in safety indications between biosimilars and their reference products and recognize the adverse drug reactions with biologics and biosimilar products. Pharmacovigilance of biologicals should contain procedures that are straightforwardly used by prescribing practitioners to guarantee that data are reliable and new safety signals are appropriately reported and allocated to the precise and accurate product.

Keywords: Biosimilars, Pharmacovigilance, Safety, Efficacy, Traceability.