FDA releases draft guidance for biosimilars

02/9/2012 | Wall Street Journal, The · Reuters · Bloomberg Businessweek

The FDA issued draft guidance for the approval of biosimilar drugs. The proposal would require companies to submit data from laboratory and clinical studies showing that biosimilars are "highly similar" to the original drugs. Dr. Rachel Sherman, the FDA's associate director for medical policy, called the process "an abbreviated pathway that will depend on existing data."

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