Samba Epis: "Soliris Similar, Additional Proof of Equivalence to Original"

Soliris Biosimilar 'Episclee'
Additional Proof of Clinical Modeling Equivalence

Samsung Bioepis announced on the 8th that it revealed additional analysis results of Soliris biosimilar 'Episcle (project name SB12, generic name Eculizumab)' through the European Hematology Association (EHA) Annual Congress held in Germany from the 8th to the 11th (local time).

Samsung Bioepis headquarters exterior. [Photo by Samsung Bioepis]

Episcle is the first biopharmaceutical developed by Samsung Bioepis in the field of hematology. In May, it received final marketing authorization from the European Commission for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH).

According to the abstract disclosed at this conference, Samsung Bioepis' modeling study further demonstrated the equivalence between SB12 and the original drug in terms of efficacy, pharmacokinetics, and pharmacodynamics, and identified influencing factors. The modeling utilized clinical phase 1 data conducted on healthy adults from November 2018 to April 2019, and clinical phase 3 data conducted on patients with paroxysmal nocturnal hemoglobinuria from July 2019 to October 2021.

The study results confirmed no differences in efficacy, pharmacokinetics, and pharmacodynamics between SB12 and the original drug. Additionally, as revealed in previous studies, body weight was identified as a factor influencing pharmacokinetics. In conclusion, the additional analysis using clinical modeling further validated that SB12 and the original drug are clinically equivalent.

A Samsung Bioepis representative stated, "This study allowed us to once again demonstrate the equivalence between SB12 and the original drug," adding, "We will continue to strive to improve patient access to high-quality biopharmaceuticals."

Soliris is a treatment for intractable rare diseases such as paroxysmal nocturnal hemoglobinuria developed by Alexion in the United States. Its global annual sales reached approximately 5 trillion KRW last year.

This content was produced with the assistance of AI translation services.