Cairo, February 13, 2023; Minapharm Pharmaceuticals and Chemical Industries S.A.E announced today the unconditional approval of a phase 1 clinical trial for its Adalimumab biosimilar through the Paul-Ehrlich Institute (PEI) and the responsible ethical committee. The product has been submitted for approval by the Egyptian health authorities and is expected to be marketed under the name Adessia.
The approved study is a multi-center, randomized, double-blind, 2-arm, parallel group trial in 154 healthy male and female participants. It compares the pharmacokinetics, safety, immunogenicity and tolerability of the Adalimumab biosimilar, Adessia, and its reference product Humira®. First dosing will occur in February 2023 and results from the study are expected by the end of this year.
Adessia represents the first biosimilar monoclonal antibody product from Minapharm’s impressive immunotherapeutic pipeline subject to international clinical development.
“The approval of Adessia’s clinical trial in Germany by the PEI comes as a continuum to Minapharm’s two decades of research, development and commercialization of genetically engineered medicines, further validating Minapharm’s regional biotech leadership and the group’s position as a global Biotech player.” said Dr. Wafik Bardissi, CEO and Chairman of the Board at Minapharm Pharmaceuticals.