Ammar Almaaytah et al., Int. J. Res. Pharm. Sci., 20202, 11(3), 3443-3449 REVIEW ARTICLE INTERNATIONAL JOURNAL OF RESEARCH IN PHARMACEUTICAL SCIENCES Published by JK Welfare & Pharmascope Foundation Journal Home Page: www.pharmascope.org/ijrps Current Status of Biosimilar Regulations in the MENA Region Ammar Almaaytah *1,2 , Hadeia Mashaqbeh 2 , Razan Haddad 2 1 Department of Pharmacy, Middle East University, Amman, Jordan 2 Department of Pharmaceutical Technology, Jordan University of Science and Technology, Irbid, Jordan Article History: Received on: 21 May 2020 Revised on: 20 Jun 2020 Accepted on: 29 Jun 2020 Keywords: Biosimilars, Biologics, MENA, EMA, Regulatory ABSTRACT This review article explores the regulatory situation of biosimilar registration pathways in the Middle East and North Africa (MENA). With most countries in the world have either adopted ofϑicial regulatory guidelines for biosimi- lar approval or are in the process of developing such guidelines, countries in the MENA region are advised to accelerate the process of adopting path- ways for biosimilar approval primarily for preventing the entry of intended copies into such markets and risking patients’ safety in addition to jeopar- dizing clinical outcomes of the different disease modalities that are treated by biologics. Additionally, biosimilars are playing a signiϑicant role in reduc- ing the signiϑicant public expenditure on biological therapy and thus increas- ing the accessibility of these medications to a larger population of patients. The article details the countries in the MENA region that have adopted ofϑicial and scientiϑic guidelines for biosimilar approval pathways. The article also draws a comparison between different countries on issues such as compara- bility studies, extrapolation of indications, interchangeability and non-clinical quality requirements. In conclusion, only four countries out of the 15 coun- tries they comprise the MENA region have adopted clear regulatory pathways for biosimilar registration and approval. This situation should be of urgent importance to policymakers responsible for public health bodies in countries that lack such guidelines due to the negative consequences that could result due to the absence of clear biosimilar regulations. * Corresponding Author Name: Ammar Almaaytah Phone: +962777658820 Email: aalmaaytah@meu.edu.jo ISSN: 0975-7538 DOI: https://doi.org/10.26452/ijrps.v11i3.2484 Production and Hosted by Pharmascope.org © 2020 | All rights reserved. INTRODUCTION The introduction of biological medicinal products in the early ’80s has revolutionized the treat- ment of several disease modalities including can- cer, autoimmune diseases and hormonal deϑicien- cies (Moroder and Musiol, 2017; Balagué et al., 2009; Oldham, 1984). Unlike their chemical medic- inal counterparts, biological products are synthe- sized based on recombinant DNA technology and in living organisms such as bacteria, yeast and mammalian cells (Reichert and Paquette, 2003). The resultant protein products are of high struc- tural complexity when compared with their classical chemical counterparts due to the three-dimensional topology of proteins when synthesized within bio- logical systems and the several variables inϑluenc- ing the manufacturing process of each biological entity (Reichert and Paquette, 2003). This com- plexity in structure has resulted in the difϑiculty of establishing a fast track generic industry for these molecules by the pharmaceutical industry as there were no technical and regulatory pathways to © International Journal of Research in Pharmaceutical Sciences 3443