Samsung Bioepis wins European approval for Stelara biosimilar

Samsung Bioepis researchers conduct test at its lab in Incheon. [SAMSUNG BIOEPIS]

Samsung Bioepis' Pyzchiva, a copycat drug of Janssen's psoriasis treatment Stelara, has been approved for sale in Europe, the company said Tuesday.

With the green light from the European Commission, Switzerland-based Sandoz will handle the marketing for the drug in Europe. Samsung Bioepis won approval for the drug in Korea earlier in the month.

Pyzchiva is an identical copy of Ustekinumab, sold under the brand name Stelara, from Belgium’s Janssen Pharmaceuticals. It is approved for the treatment of certain autoimmune disorders in gastroenterology, dermatology and rheumatology.

Stelara’s patent expired in September 2023 in the United States and in January 2024 for most parts of Europe. Its annual revenue stands at some $10.9 billion globally.

Biosimilars, according to the U.S. Food and Drug Administration (FDA), are biological products that are approved based on proof that they are highly similar to other FDA-approved products. The drugs have no clinically meaningful difference in terms of safety or effectiveness from the reference product, but they cost less.

Samsung Bioepis has released a total of 10 biosimilars in the European markets so far.

“We are proud to have our fourth immunology biosimilar approved in Europe,” said Jung Byoung-in, vice president at Samsung Bioepis. “With the latest approval, we are pleased to make important progress toward providing additional treatment options for patients suffering from chronic autoimmune diseases in Europe.”

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