Dr. Dr. Michel Mikhail
International Expert in Biosimilars, USA
Biography
Michel Mikhail has more than 25 year’s pharmaceutical industry experience. He is an Expert in Biosimilars, involved in the global development and worldwide regulatory approval of blockbuster monoclonal antibodies medicines and involved in shaping the EU biosimilars guidelines and their review, the WHO guidelines, ICH guidelines and now in the US-FDA biosimilars guidelines. He is a Chartered Expert in Pharmacology-Toxicology, a chartered Clinical Expert as well as a Chartered Analytical Expert. He is a Member of the Expert Committee of the Government Federal Institute of Risk Assessment (BfR) Germany and served as a Member of the Expert Committee for Toxicology of the United States Pharmacopoeia (USP).
Abstract
Abstract : Biosimilars interchangeability: The draft guidance in the USA