Evaluation of pharmaceutical equivalency of manufactured generic drugs in UAE

Generics/Research | Posted 10/02/2023 post-comment0 Post your comment

Generic medicines are pharmaceutical products manufactured to be equivalent to the brand or innovator drug products. They represent the majority of worldwide prescribed medicines; therefore, their quality is critical to ensure equivalent therapeutic outcomes

46 MD001580

Al Ali L et al. carried out a study aimed to evaluate the pharmaceutical equivalency of locally and regionally manufactured generic pharmaceutical products being sold in the United Arab Emirates (UAE) market to enhance public confidence, promote their utilization, and reduce treatment costs [1]. 

The authors selected for the study three drugs that they considered to be representative from three different pharmacological classes from the UAE market. These generic drugs were tadalafil, rosuvastatin, and acetaminophen. At least two products for each locally (L) and regionally (R) manufactured generic drugs were evaluated according to the USP criteria in comparison with the brand (B) comparator product.

In this study, all comparative tests were performed before storage, and 3 and 6 months after storage during the accelerated stability study performed under the conditions for climatic zone IV (40°C ± 2°C / 75% RH ± 5% RH). Although results were statistically different from the comparators using ANOVA and Tukey’s Kremer post hoc tests, all performed tests (dimensions, friability, disintegration, content uniformity, and dissolution) were within the USP acceptance limits, except one generic product. Significant changes were observed following their storage over the 6 months of accelerated stability studies, however, without failing the USP limits. Only one locally manufactured acetaminophen generic product failed the USP dissolution tests before and after its storage and failed the disintegration test following its storage under accelerated conditions of zone IV.

The authors concluded that the majority of the locally and regionally manufactured generic products being sold in the UAE market were of good quality and performed similarly to their comparators. Nevertheless, a continuous independent quality evaluation for the marketed generic drugs is essential to enhance public confidence [1].

Conflict of interest
The authors of the research paper [1] declared that the work was supported by the University of Sharjah Graduate Studies’ Student Grant.

Editor’s comment
Readers interested to learn more about generics substitution are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal: 

A review on patient perspectives on generics substitution: what are the challenges for optimal drug use 

GaBI Journal is indexed in Embase, Scopus, Emerging Sources Citation Index and more

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.

GaBI Journal Citation Impact
2.2 – CiteScore 2021 (calculated on 5 May 2022)
2.5 – CiteScoreTracker 2022 (Last updated on 5 January 2023)

Submit a manuscript to GaBI Journal

Related articles
What is meant by a generic medication and generic equivalence 

Biosimilar regulation in the Middle East

Suggestions for increasing generics use in Abu Dhabi

LATIN AMERICAN FORUM
The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View the latest headline article: DARS: avance el desarrollo de biosimilares en los EE. UU

Browse the news in the Latin American Forum!

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.

FORO LATINOAMERICANO
Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Ver el último artículo de cabecera: DARS: avance el desarrollo de biosimilares en los EE. UU

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. 

 

Reference
1. Al Ali L, Jagal J, Joseph J, et al. Pharmaceutical equivalency of locally and regionally manufactured generic pharmaceutical products in UAE. Saudi Pharm J. 2022;30(9):1243-51.

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2023 Pro Pharma Communications International. All Rights Reserved.

 

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010