Samba Epis: "Positive Opinion on Soliris Biosimilar Approval in Europe"

Soliris Biosimilar 'Episcle'

Samsung Bioepis announced on the 1st that it has obtained a positive opinion for the marketing authorization of 'Episclee' (project name SB12), a biosimilar of the paroxysmal nocturnal hemoglobinuria treatment 'Soliris,' from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA).

Samsung Bioepis headquarters exterior. [Photo by Samsung Bioepis]

Soliris, developed by Alexion in the United States, is a treatment for rare and intractable diseases such as paroxysmal nocturnal hemoglobinuria, and is an ultra-high-priced biopharmaceutical with annual treatment costs reaching hundreds of millions of won. This disease involves the destruction of red blood cells within blood vessels, leading to thrombosis and hemolysis at night, accompanied by hemoglobinuria. It can cause complications such as acute renal failure, infections, and bleeding, and can be fatal in severe cases. Soliris's global annual sales last year amounted to $3.762 billion (approximately 4.7 trillion KRW).

Episclee is the first product developed by Samsung Bioepis in the hematology field. The company expects to obtain official marketing authorization after the final review by the European Union's Executive Commission, which generally takes about 2 to 3 months.

Samsung Bioepis has currently commercialized a total of six biosimilar products in the European market. With the recent recommendation for Episclee's approval, the company has expanded its portfolio into the hematology field, following treatments for autoimmune, oncology, and ophthalmology diseases.

A Samsung Bioepis representative stated, "Episclee is a drug that can realize the essential meaning of biosimilar development by improving patient access to ultra-high-priced biopharmaceuticals," adding, "We will strive to provide more treatment opportunities to patients suffering from rare diseases."

Meanwhile, Samsung Bioepis demonstrated pharmacokinetic (PK) equivalence between SB12 and the original drug through a Phase 1 clinical trial conducted from November 2018 to March 2019. Subsequently, through a Phase 3 clinical trial conducted from August 2019 to October 2021 involving patients with paroxysmal nocturnal hemoglobinuria, clinical equivalence between SB12 and the original drug was confirmed.

Considering the burden of drug costs, Samsung Bioepis also provided extended supply by offering SB12 free of charge for up to two years to patients who participated in the clinical trials.