Posted by Michael Wonder on 30 Jan 2023
Sandoz receives positive CHMP opinion for citrate free high concentration formulation of adalimumab biosimilar
30 January 2023 - Sandoz is seeking approval of high concentration formulation adalimumab for use in all indications of reference medicine.
Sandoz today announced that the CHMP of the EMA has adopted a positive opinion for marketing authorisation for a citrate free high concentration formulation of its biosimilar Hyrimoz (adalimumab).
The authorisation includes all indications covered by the reference medicine: rheumatoid arthritis, Crohn's disease, ulcerative colitis, plaque psoriasis and uveitis.
