Once approved by the MFDS, Samsung Bioepis’ manufacturer Samsung Biologics will be producing SB4, which is a biosimilar of Pfizer’s Enbrel used to treat rheumatoid arthritis, ankylosing spondylitis, and psoriasis. (image: Korea Bizwire)
SEOUL, Mar. 11 (Korea Bizwire) — Samsung Group’s pharmaceutical subsidiary Samsung Bioepis will be the third Korean company to manufacture and distribute biosimilar products.
The company confirmed that its ‘SB4′ Enbrel biosimilar drug has advanced into regulatory review for manufacturing and marketing by the Ministry of Food and Drug Safety (MFDS), according to an announcement on March 10. Currently, biosimilar pharmaceuticals from Celltrion and Hanhwa Chemical have been approved by the MFDS.
Once approved by the MFDS, Samsung Bioepis’ manufacturer Samsung Biologics will be producing SB4, which is a biosimilar of Pfizer’s Enbrel used to treat rheumatoid arthritis, ankylosing spondylitis, and psoriasis. Samsung Bioepis also submitted an application for regulatory approvals to the European Medicines Agency (EMA) in January as well. Pfizer’s Enbrel is a blockbuster drug which has generated sales of 8.54 billion US dollars worldwide.
Samsung Bioepis is a rapidly growing pharmaceutical company, as it only took three years to fully develop a biosimilar drug, while other companies have usually required eight to ten years to reach the same milestone.
By J.W. Choi (summerchoi@koreabizwire.com)
