Samsung Bioepis has five years of data on biosimilar

Samsung Bioepis said Monday that a five-year follow-up study of the company's biosimilar product Ontruzant confirmed its safety and long-term effectiveness.

Samsung Bioepis’ headquarters in Songdo, Incheon [SAMSUNG BIOEPIS]

Samsung Bioepis said Monday that a five-year follow-up study of the company's biosimilar product Ontruzant confirmed its safety and long-term effectiveness.

The drug is an identical copy of Trastuzumab, better known as Herceptin from California-based Genentech.

Ontruzant, the company's second biosimilar product, has been sold on the Korean and European markets since 2018 and in the United States since 2020. Biosimilars, according to the U.S. Food and Drug Administration, are biological products that are approved based on proof they are highly similar to other approved products. The drugs have no meaningful clinical differences in terms of safety or effectiveness from the reference product.

The company observed a total of 367 patients with early and advanced stages of breast cancer for about 68 months, with 186 people injected with Ontruzant and 181 with the reference drug. According to results revealed in the European Society for Medical Oncology (ESMO) Virtual Congress 2021, five-year overall survival rates were roughly 93.1 percent for the patients injected with the company’s biosimilar and 86.7 percent in the control group. The rate refers to the percentage of people in a study group who are alive five years after the start of treatment.

Only one patient in the group injected with Ontruzant experienced decrease in ejection fraction, which means heart failure, while two people experience it in the control group. There were no reported cases of symptomatic congestive heart failure or cardiac death reported in either group.

The follow-up results prove that “Ontruzant is similar with the reference drug in terms of cardiac safety profiles and long-term efficacy,” Samsung Bioepis said.

“The results presented at this year’s ESMO is the data that we could monitor for the longest time period for patients with early and advanced breast cancer that were treated with the biosimilar,” said Shin Dong-hoon, vice president and head of medical and lifecycle safety team at Samsung Bioepis. “This valuable data signals our continuous dedication to producing high-quality treatments with proven efficacy and safety. We remain committed to patients we serve through our rigorous research and development to ensure quality treatment.”

Ontruzant’s global sales were $45 million in the first half of the year, up 13 percent on year.

BY SARAH CHEA [chea.sarah@joongang.co.kr]