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Home » Federal Circuit: FDA Approval Required Before Biosimilar Applicant Gives 180-Day Notice
Federal Circuit: FDA Approval Required Before Biosimilar Applicant Gives 180-Day Notice
Biosimilars makers must have FDA approval of their product before giving the reference product manufacturer 180-day notice of first commercial marketing, the Federal Circuit Court of Appeals ruled Tuesday — in a decision that bars Sandoz from marketing its Neupogen biosimilar until Sept. 2.