European Commission Approves First Tocilizumab Biosimilar

The European Commission has granted marketing authorization for Fresenius Kabi’s tocilizumab biosimilar, Tyenne.

This is the first tocilizumab biosimilar granted marketing authorization in Europe, according to a September 19 press release from manufacturer Fresenius Kabi. Tyenne is indicated for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, CAR-T cell-induced severe or life-threatening cytokine release syndrome, and COVID-19.

Tyenne was found to have “comparable quality, safety, and efficacy” to the reference product RoActemra (tocilizumab), an interleukin-6 receptor inhibitor that was first authorized in the European Union in 2009, according to the European Medicines Agency opinion letter. The biosimilar will be available both in a 162 mg/mL prefilled syringe for subcutaneous injection and as a 20 mg/mL concentrate for solution for intravenous administration.

“Being on the cutting edge of proposing an affordable, high-quality, and safe tocilizumab treatment option to healthcare providers and patients living with autoimmune diseases is an exciting step in our mission to provide access to alternative treatment options,” said the company’s Chief Executive Officer Pierluigi Antonelli in a statement. 

The US Food and Drug Administration is currently reviewing Fresenius Kabi’s Biologic License Application for the drug.

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