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Report: FDA to publish new guidance on biosimilars, generic opioids


WASHINGTON — The Food and Drug Administration has revealed plans to publish new guidance documents on biosimilars labeling and evaluating abuse-deterrent properties of generic solid oral opioids, according to a report by the Regulatory Affairs Professional Society.

The FDA is expected to come out with the new guidance documents before the end of the year.

According to the report, the agency will need to determine what “generic” name each biosimilar will go by. Given that biosimilar drugs have inherent differences, some industry sources have pushed for biosimilars to contain unique suffixes to help facilitate the reporting of adverse events.

With regard to the second document, the FDA appears ready to weigh in the topic of abuse deterrent qualities of generic opioids. According to the report, abuse-deterrent qualities do not necessarily extend the original drug’s patent protection or marketing exclusivity. Some industry players have expressed concern that generics could increase rates of abuse and are calling on the agency to hold generic opioid products to the same abuse-deterrence standards as the original drug.


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