Samsung Bioepis biosimilar gets 'positive opinion' from European agency

Samsung Bioepis CEO Christopher Ko

South Korea's Samsung Bioepis said its biosimilar drug Benepali, used in the treatment of rheumatoid arthritis and other autoimmune diseases, has received a "positive opinion" from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).

The drug is a biosimilar of Enbrel (etanercept) and Samsung Bioepis said this was the first time the CHMP has given a positive opinion for an etanercept biosimilar. Enbrel is made by Amgen ($AMGN) and marketed outside the United States by Pfizer ($PFE).

"We are very pleased to have developed the first etanercept biosimilar to receive a positive CHMP opinion," Christopher Hansung Ko, CEO of Samsung Bioepis, said in a statement. "By leveraging our strengths in product development and quality assurance, we will continue to focus on developing affordable, high-quality biologic treatment options for patients in Europe who need these life-enhancing medications."

The drug still faces an approval process from the European Commission, which can take two or more months, according to a report by Fox News.

The etanercept biosimilar will be the second antibody product to come to market in Europe. Doctors there can already prescribe the biosimilar infliximab, which is a copy of Merck's ($MRK) Remicade, Fox reported.

- here's the report from Fox
- here's the release