Eculizumab biosimilar gets positive CHMP opinion

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for EPYSQLI™, a biosimilar referencing Soliris (eculizumab), also known as SB12.

EPYSQLI has been recommended for approval in patients with paroxysmal nocturnal hemoglobinuria (PNH). According to National Organization for Rare Disorders, PNH is a rare disease where red blood cells break apart prematurely.

“We are pleased to see EPYSQLI becoming our first biosimilar in haematology to be recommended for approval in Europe. This marks another significant milestone for… people living with PNH,” commented Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis.

The biosimilar’s European approval

The CHMP’s positive opinion on EPYSQLI was based on a totality of evidence including analytical, non-clinical data, and clinical data. A randomised, double-blind, multicenter, cross-over Phase III study of SB12 demonstrated equivalent clinical efficacy of SB12 and reference eculizumab by evaluating lactate dehydrogenase (LDH) in PNH patients. This indicated that SB12 was bioequivalent to the reference eculizumab.

The Phase III study

The trial evaluated 50 patients who received 600mg of SB12 or reference eculizumab intravenously every week for the first four weeks. Then 900mg for the fifth week, followed by 900mg every two weeks thereafter. The treatment was switched to reference eculizumab or SB12 at Week 26. Switched treatment was provided until Week 50.

The CHMP’s positive opinion of the biosimilar will now be referred to the European Commission (EC) which will decide whether to grant a marketing authorization for EPYSQLI.