Comprehensive Study on Regulatory Requirement for Biosimilars in Egypt and Its Comparision with Europe, U.S. and Canada

Abstract

Biosimilars are highly similar but not identical molecules that claim to have similar quality, safety and efficacy of original (innovator/ reference) products. Such critical products are high on the treatment guidelines recommended for complex diseases with high death and disability burdens. The regulatory policies with respect to the biopharmaceutical sector focusing on biosimilars (Similar Biotherapeutic Products) are described. Biosimilars started accessing the Egyptian market long time before the government established a proper regulatory structure/pathway to regulate such products. It is expected that biosimilars will start accessing the Egyptian market with high influx rate during the upcoming years as many originator bio pharmaceuticals are losing patent protection during 2013-2020. Such influx requires progressive policy thinking and well-resourced regulatory structures to properly regulate the complex pharmaceutical biotechnology market. It is also necessary to ensure the protection of public health, prevention of potential regulatory failures and promoting investment in local production for improving access to medicines. This research seeks to understand the current debate in the bio-similar conversation, and examine whether there is a clear regulatory path to market for bio-similar in semi-regulated market (Egypt) compared to the regulated markets like US, Europe and Canada.