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.