Posted by Michael Wonder on 17 Jun 2022
Sandoz application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA
17 June 2022 - Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics study.
Sandoz today announced that the EMA has accepted the application for high concentration formulation 100 mg/mL of its biosimilar Hyrimoz (adalimumab) for regulatory review.
The application includes all indications covered by the reference medicine, including rheumatoid arthritis, Crohn's disease, ulcerative colitis, plaque psoriasis, and uveitis.
