EC approval for biosimilar PNH medicine Epysqli

30 May 2023

South Korean drugmaker Samsung Bioepis today announced that the European Commission (EC) has granted marketing authorization for Epysqli, a biosimilar to medicine to AstraZeneca’s (LSE: AZN) Soliris (eculizumab), for the treatment of adult and child patients with paroxysmal nocturnal hemoglobinuria (PNH).

This approval follows a positive recommendation from the European Medicines Agency’s (EMA) human medicines committee (CHMP) at its March meeting. Soliris generated sales of $834 million for AstraZeneca in the first quarter of this, down 13% on the like year-earlier period.

“The approval of Epysqli, Samsung Bioepis’ first hematology biosimilar, reflects our ongoing endeavors to introduce more treatment options for PNH patients in Europe,” said Byoungin Jung, vice president and regulatory affairs team leader, Samsung Bioepis. “The approval marks another step towards enhancing the lives of patients, including those with rare diseases, through our pioneering and innovative use of science and technology,” she added.

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