Guidance and List of Requirements for Registration of Biosimilars Products

Lebanon chose to follow the “GUIDELINES ON EVALUATION OF SIMILAR BIOTHERAPEUTIC PRODUCTS (SBPs)” issued by the WHO, as adopted  by the 60th  meeting of the WHO Expert Committee  on  Biological Standardization,  19-23 October 2009 to evaluate the submitted SBS Files.

• Guidance for Registration of Similar Biological Medicinal products (Biosimilars)
• List of Requirements for the registration of Biosimilar products according to CTD format