European Commission grants approval to the first Tocilizumab biosimilar

The European Commission has granted marketing authorization to Fresenius Kabi for its tocilizumab biosimilar, Tyenne. This marks the first approval of a tocilizumab biosimilar in Europe, as announced in a press release on September 19 by the manufacturer, Fresenius Kabi. Tyenne is indicated for treating various conditions, including 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.

The European Medicines Agency opinion letter has confirmed that Tyenne demonstrates "comparable quality, safety, and efficacy" to the reference product RoActemra (tocilizumab), an interleukin-6 receptor inhibitor that gained initial authorization in the European Union back in 2009. Tyenne will be available in two forms: a 162 mg/mL prefilled syringe for subcutaneous injection and a 20 mg/mL concentrate for a solution suitable for intravenous administration.

Company’s CEO Pierluigi Antonelli said, “Being on the cutting edge of proposing an affordable, high-quality, and safe tocilizumab treatment option to health care providers and patients living with autoimmune diseases is an exciting step in our mission to provide access to alternative treatment options.