The US Food and Drug Administration (FDA) will release three separate
guidance documents on biosimilars "before the end of the year," said
Janet Woodcock, director of FDA’s Center for Drug Evaluation and
Research, according to a report from BioCentury. Woodcock
announced the plans during remarks before a recent conference on rare
diseases and orphan products. She did not go into specifics about what
the documents will address, but an FDA spokesperson promised they will
"cover the most pressing scientific issues facing a manufacturer as they
contemplate developing a biosimilars program."
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