The Central Administration for Pharmaceutical Affairs announces the Ministerial decree 150/2015 regarding Guidelines for Registration of Biological products in Egypt.
What is a biosimilar medicine?
A similar biological medicinal product having the same active substance, dosage form, concentration and route of administration of a reference biological product and has proven through a comparability program that its quality, safety and efficacy are highly similar to a reference product when prescribed in a claimed indication.
The Aim of the Biosimilar approach is to demonestrate close similarity of the biosimilar product in terms of quality, safety and efficacy to a selected reference medicinal biological product.
Our principle aim is to:
Facilitate the registration of biosimilar products in Egypt through an abbreviated pathway.
Scope:These guidelines apply to well characterize Biological Medicinal Products developed by means of biotechnology (including recombinant DNA technology). Vaccines and plasma derived products are excluded from the scope of these guidelines.
Approved guidelines by Ministerial decree 150/2015
Minister decree 150/2015
Guidelines for Registration of Biological products in Egypt
Biosimilars Second meeting 31th of March,2014
2nd Draft Biosimilar guidelines
Biosimilars First meeting 24th & 25th of February ,2013