The supplemental biological license application (sBLA) was submitted by Bristol-Myers Squibb Company to meet expected long-term demand for Orencia.
Jung-Jin Seo, chairman and CEO of Celltrion, said: “We are pleased to continue our strategic business partnership with Bristol-Myers Squibb. 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. 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.”