Egypt, last month issued the draft guidelines for Biosimilars Registration on Egyptian Drug Authority website.
The Central administration for pharmaceutical affairs (CAPA) announced the release of the 1st draft guideline for registration of biosimilars in Egypt.
Regulations for registration of biological products has been recently implemented in Egypt in 2009 through the Minister decree 297/2009 adopting guidelines for submission of registration dossier based on full data (quality, preclinical and clinical). The biosimilars guideline has been developed in order to facilitate the registration of biosimilar products in Egypt through an abbreviated pathway.
The draft guideline states that, two approaches for registration of a similar version of a biological product can be applied:
1- Stand-alone approach: the manufacturer perform complete product development program (quality, pre-clinical and clincal studies) (excluded from the scope of this guideline).
2- Biosimilar approach: the manufacturer perform complete product CMC development process in addition to comparability quality exercise, and reduced preclinical and clinical comparability studies inorder to demonstrate biosimilarity of the proposed biological product to a reference
Egyptian Drug Authority (EDA) divides the registration process into two and states the differences between importing a biosimilar and developing and manufacturing a biosimilar locally in Egypt.
WHO, ICH and EMA biosimilar guidelines are taken as a reference while developing this first draft for Egypt.
The guideline can be reached from here.