Production and analysis of biosimilars and follow on biologics in developing countries

4^th International Conference on Pharmaceutical Regulatory Affairs

September 08-10, 2014 DoubleTree by Hilton Hotel Raleigh-Brownstone-University, USA

Wael Ebied

Scientific Tracks Abstracts: Pharmaceut Reg Affairs

Abstract :

Although management of chronic diseases has been a major challenge for healthcare systems in developed and developing countries, biopharmaceuticals have been successful in treating many life threatening conditions. However, the high cost of these agents restricts their availability to countries where patients and/or healthcare systems are able to afford them. Licensing these biopharmaceuticals as biosimilars after expiration of their patents might increase access to these medicines at an affordable price in developing countries. South Egypt Drug Industries Company (SEDICO) is an Egyptian pharmaceutical company that got an opportunity to manufacture some of these drugs. SEDICO biotech products, such as Insulin, erythropoietin, streptokinase, angiokinase, follicle-stimulating hormone (FSH), aprotinin, filgrastim (G-CSF) and somatropin, have been available in the Egyptian market for more than seven years. In this article, biosimilars which were tested and examined over years in SEDICO was chosen as a representative example of biotech products in south countries. The results confirmed that most of SEDICO biosimilar products can compete with the originator biologics in the Egyptian market with high quality challenge and lower cost opportunity.

Biography :

Wael Ebied has completed his BPharm at the age of 23 years from Tanta University and postgraduate studies in Al Azhar University School of Pharmacy. He is the Senior Technical, QA & EHS manager at SEDICO Pharmaceuticals and products transfer project & LSS team leader for Merck & Co. external partner. He has published some papers in reputed journals.