FDA releases draft guidance for biosimilars

Source: BIO SmartBrief

FDA releases draft guidance for biosimilars
The FDA issued draft guidance for the approval of biosimilar drugs.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, and in some cases trials may not be required. BIO President and CEO Jim Greenwood welcomed the release. “We look forward to reviewing the drafts in detail to ensure that they comply with our key principles,” he said. Reuters (2/9), The Pharma Letter (U.K.) (subscription required) (2/10), Bloomberg Businessweek (2/10)


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