Samer M Al-Hulu, Assistant Professor of Microbiology, has completed his PhD from Babylon University/College of Science. He has published more than 14 papers in microbiology field. He has completed training at Ministry of Health at Laboratory of Babylon Maternity and Children Hospital. Now, he is working at Al-Qasim Green University/College of Food Science.

Biosimilars are \\\"similar but not the same\\\" to the original biologic innovator product. Some of challenges that effect on biosimilars development such as Verification of similarity, not having of unique name, findings of biosimilars guidelines, safety, labeling of biosimilar and regulatory framework for assessing of biosimlar. Development of biosimilars achieved by finding of unique name, using of powerful analytical tools for biosimilars comparability to the reference, quality by design studies, using of statistical method for reducing of simple size of biosimalir clinical trial and post-marketing surveillance studies to establish biosimilar safety, and single use bioprocessing (single use bioreactor) for biosimilar production for meeting their clinical manufactures. Pharmacovigilance programs are important for establishing clinical databases. A new generation of biosimilars such as bio-betters, monoclonal antibody biosimilars are having more acceptability and are approved.

Major in Biochemistry at the Université de Montreal, Canada, Marcel continued his graduate studies (M.Sc and Ph.D) in physiology at the Université de Montreal as well as he conducted a clinical research associate program. His academic background and his professional journey in Biotechnology industries in Montreal allowed him to acquired useful and tremendous experience in cell culture and in many types of protein expression platforms with their respective bioprocesses. In the summer of 2010, he moved to Lebanon to join the academic team of the Faculty of Health Sciences at the University of Balamand as an Assistant-Professor. Later on, he joined Benta Pharma Industries as the Associate Director Biotech in charge of developing the Biotech facility and the production/characterization of several Biotech products. \r\n

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, 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.