이 누리집은 대한민국 공식 전자정부 누리집입니다.

한상넷

비즈니스 정보

Biz News Korea(Eng)

U.S. FDA approves Samsung Bioepis’s biosimilar Renflexis

Collected: 2017.04.23

Distributed: 2017.04.24

Source: Go Direct

Samsung Bioepis Co., a biotechnology research and development unit of South Korea’s largest conglomerate Samsung Group, said Saturday that it has received marketing authorization from the U.S. Food and Drug Administration (FDA) for Renflexis, a biosimilar referencing Janssen’s Remicade.

Renflexis, which is a version of infliximab, is a treatment of rheumatoid arthritis, ankylosing spondylitis and Crohn’s disease in adults. Its reference drug is Remicade, blockbuster drug sold by Janssen, a pharmaceutical division of multinational medical company Johnson & Johnson.

The company had filed for the U.S. FDA approval in March last year.

In Korea, the drug was approved by the Ministry of Food and Drug Safety December 2015 under the brand name of Renflexis. It also gained marketing approval in Europe and Australia last year. It is sold as Flixabi in Europe.

By Shin Chan-oak

List

Previous: S. Korean financial groups report earnings surprise in Q1 on higher NIM

Next: This week’s heads-up from Pulse