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After shoring up quality control at its Reykjavik manufacturing facility, the biotech has resubmitted a BLA to the FDA seeking an interchangeability designation for its Humira biosimilar. ....
FDA rejects Teva's high-potency biosimilar of Humira again pharmaphorum.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pharmaphorum.com Daily Mail and Mail on Sunday newspapers.
The FDA has approved Hulio, a biosimilar of Humira which will be available in 2023, for treating adults with Crohn’s disease and ulcerative colitis. ....