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June 20, 2022

EMA accepts Sandoz’s application for high concentration of biosimilar

In a Phase I PK bridging study, Hyrimoz 50 mg/mL2 and Hyrimoz HCF had similar safety and immunogenicity.

The European Medicines Agency (EMA) has accepted an application of Novartis’ subsidiary Sandoz for high concentration formulation 100mg/mL (HCF) of its biosimilar Hyrimoz (adalimumab) for regulatory review. 

A human immunoglobulin G1 (IgG1) monoclonal antibody, adalimumab acts on tumour necrosis factor-alpha (TNF-a). 

Initially, the adalimumab reference medicine, Humira, obtained approval with an adalimumab concentration of 50mg/mL.

The EMA granted approval for Humira HCF, which comprises 100mg/mL adalimumab, in 2015.

The latest application comprises all indications covered by the reference medicine, including Crohn’s disease, plaque psoriasis, ulcerative colitis, rheumatoid arthritis and uveitis.

If approved, the Hyrimoz (100 mg/mL) citrate-free HCF could provide low injection volume and potentially lower the number of injections needed for patients who require an 80mg dosage. 

To extend an improved and familiar experience for patients, Hyrimoz HCF will have the same auto-injector as Hyrimoz 50mg/mL.

The comprehensive submission package to the regulatory agency comprises data from a Phase I pharmacokinetics (PK) bridging study carried out by the company that compared Hyrimoz 50mg/mL2 and Hyrimoz HCF. 

According to the findings, the study met all its primary goals and showed comparable pharmacokinetics as well as similar safety and immunogenicity between Hyrimoz 50mg/mL and Hyrimoz HCF.

Sandoz Biopharmaceuticals Development global head Florian Bieber said: “At Sandoz, we are constantly looking for ways to meet the changing needs of patients and health care providers.” 

“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.”

The company currently has an established portfolio of biosimilars in immunology, including Erelzi, Zessly and Rixathon.

In October last year, Sandoz concluded the acquisition of GlaxoSmithKline’s cephalosporin antibiotics business for $500m.

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