Contract manufacturer gains Orencia approval
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The FDA has approved Celltrion to serve as a contract manufacturer to produce Orencia (abatacept).
The drug, which was developed by Bristol-Myers Squibb, is used to treat rheumatoid arthritis.
Bristol-Myers Squibb submitted a Supplemental Biological Licence Application (sBLA) to the FDA, in a bid to increase production levels to meet expected long-term demand for Orencia.
Jung-Jin Seo, chairman and chief executive officer 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.”
Celltrion, which is based in South Korea, is the largest biopharmaceutical manufacturing facility in the Asia-Pacific region.
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