- Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics study
- Adalimumab’s high-concentration 100 mg/mL formulation aims to provide an enhanced yet familiar experience for patients
- Submission builds on Sandoz’ well established biosimilar immunology portfolio in Europe
Basel, June 17, 2022 — Sandoz, a global leader in generic and biosimilar medicines, today announced that the European Medicines Agency (EMA) has accepted the application for high concentration formulation 100 mg/mL (HCF) 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 uveitis1.
Upon approval, the Hyrimoz (100 mg/mL) citrate-free HCF would offer reduced injection volume and potentially decrease the number of injections required for patients who need 80 mg dosing. Hyrimoz HCF will have the same auto injector as Hyrimoz 50 mg/mL, aiming for an enhanced yet familiar patient experience.
“At Sandoz, we are constantly looking for ways to meet the changing needs of patients and health care providers,” said Florian Bieber, Global Head Biopharmaceuticals Development, Sandoz. “By committing to bring biosimilar formulations such as Hyrimoz citrate-free HCF to patients, we are serving a critical need in expanding access to important medicines and fueling pharmaceutical…
