|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