Novartis division Sandoz application for proposed biosimilar Hyrimoz's high concentration formulation accepted by EMA
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.
Basel: Sandoz has 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 uveitis.
Adalimumab is a human immunoglobulin G1 (IgG(1)) monoclonal antibody targeting tumor necrosis factor alpha (TNF-a). The adalimumab reference medicine (Humira*) was first approved with an adalimumab concentration of 50 mg/mL. In 2015, the EMA and US FDA approved Humira HCF, which contains adalimumab at a concentration of 100 mg/mL.
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.
"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 innovation."
As part of the comprehensive submission package to the EMA, Sandoz conducted a Phase I pharmacokinetics (PK) bridging study comparing Hyrimoz 50 mg/mL and Hyrimoz HCF. This study met all its primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity between the Hyrimoz 50 mg/mL and Hyrimoz HCF.
This potential approval of Hyrimoz HCF builds on the already approved and well-established Sandoz biosimilar portfolio in immunology, including Erelzi (biosimilar etanercept), Zessly (biosimilar infliximab) and Rixathon (biosimilar rituximab, including rheumatoid arthritis indication). Sandoz' Hyrimoz 50 mg/mL was first approved by the European Commission in July 2018 and launched in several European countries shortly thereafter.
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