Biologics and Biosimilars

Biography

Biography: Marcel Bassil

Abstract

Biosimilars are those biologics which are developed after patent expiration of innovator biopharmaceuticals. They are known as similar biologics, follow-on biologics, subsequent-entry biologics, and second-entry or off-patent biotechnology in different countries. Furthermore, they require separate marketing approval since they are not generic versions of biologics which is new in the MENA region. They establish a group of new molecules owing to a number of heterogeneities as compared to the reference innovator biologics. Moreover, this presentation will also discusses the major challenges involved in the manufacturing of Biosimilars and the required documentation on quality, safety and efficacy including comparability exercises as well as the single most important factors affecting the Biomanufacturing capacity in the region. Moreover, Biologics are one of the most important growth drivers for global pharmaceutical market but several challenges impede the way of growth of Biosimilars in the emerging markets. However, we will also take into consideration some trends that promise the bright future of Biosimilars in the MENA region. Finally, we will throw light on the regulatory guidelines of different countries especially in the MENA region and their impacts on the development of Biosimilars.