The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for marketing authorization for a citrate-free high concentration formulation (HCF) of Sandoz’s biosimilar, Hyrimoz (adalimumab).
Upon approval and EU market entry, the adalimumab citrate-free HCF (100 mg/ml) formulation will offer reduced injection volume and potentially decrease the number of injections required for patients who need 80 mg/mL dosing, according to Sandoz.
The marketing authorization would include all indications covered by the adalimumab reference medicine, Humira, including rheumatoid arthritis, Crohn's disease, ulcerative colitis, plaque psoriasis and uveitis.
Safety and immunogenicity data
Sandoz conducted a Phase I pharmacokinetics (PK) bridging study comparing its approved adalimumab 50 mg/ml with the 100 mg/ml (HCF) and submitted that data to the EMA. “The study met all its primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity between the two concentrations.”
Adalimumab is a human immunoglobulin G1 monoclonal antibody targeting tumor necrosis factor alpha (TNF-a). Humira was first approved with an adalimumab concentration of 50 mg/ml. In 2015, the EU and US regulatory agencies approved Humira HCF, which contains adalimumab at a concentration of 100 mg/ml.
Looking to developments in the US for Hyrimoz and the US Food and Drug Administration (FDA) approved the 50 mg/mL version way back in 2018. Despite that regulatory green light, the drug will not be available to patients until the end of September 2023 due to the outcome of the patent infringement litigation settled between AbbVie and Sandoz in 2018.
Meanwhile, July last year saw the FDA accept for review the company's sBLA for Hyrimoz 100 mg/mL (HCF).
Sandoz counts eight marketed biosimilars in its current portfolio and a further 15 such products in various stages of development.