Breaking News

Celltrion Gets CMO Approval for Orencia

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

Celltrion, Inc., a Korean biopharmaceutical company, has received approval from the FDA to serve as a CMO for Bristol-Myers Squibb to produce Orencia, a treatment of rheumatoid arthritis. BMS submitted an sBLA to meet expected long-term demand for the biologic drug.

“We are pleased to continue our strategic business partnership with BMS. Achieving sBLA approval from the FDA to manufacture Orencia is an important milestone that reinforces our vision to become a fully integrated global biotechnology company,” said Jung-Jin Seo, chairman and chief executive officer of Celltrion. “Celltrion is dedicated to working with our business partners to exceed their quality requirements while providing manufacturing value. It is our commitment to quality service that will attract other global biopharmaceutical companies to our manufacturing capabilities.”

In a press statement, Celltrion noted that it “the only Asian large-scale cell-culture contract manufacturing facility which has successfully obtained approval from the U.S. FDA.”

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters