이 누리집은 대한민국 공식 전자정부 누리집입니다.
Biz News Korea(Eng)
U.S. FDA begins review process of Samsung’s Lantus biosimilar
- Collected
- 2016.08.09
- Distributed
- 2016.08.10
- Source
- Go Direct
Samsung Bioepis, a biotechnology research and development unit of South Korea’s largest conglomerate Samsung Group, said on Monday that the U.S. FDA started reviewing the new drug application of its biosimilar SB9. Industry experts expect the new diabetes drug will be available in the U.S. market around the end of next year given the FDA review process usually takes over a year.
SB9 is a biosimilar drug of Sanofi SA’s diabetes drug Lantus. U.S.-based Merck & Co. and Samsung Bioepis agreed on the joint development of the biosimilar in 2013. The American pharmaceutical company is responsible for development, clinical trial, regulatory approval, and marketing.
Currently, Samsung Bioepis has a pipeline of six biosimilar drugs, including SB9. Of these, two autoimmune disease drugs (Benapali and Flixaby) were already approved in Korea and Europe. Benapali, a biosimilar drug of Enbrel, and Flixaby, a biosimilar drug of Remicade, were launched in Europe.
The company has also filed a new drug application for SB5, a biosimilar version of blockbuster rheumatoid arthritis drug Humira, in Europe. Cancer treatments SB3, a biosimilar drug of Herceptin, and SB8, a biosimilar drug of Avastin, are under phase III trials.
The company also filed an application for approval of SB9 with the European Medicines Agency last year and the drug is currently under review.
By Lee Dong-in
[ⓒ Pulse by Maeil Business News Korea & mk.co.kr, All rights reserved]