Reports: Legislation proposed for biosimilars, overseas drug manufacturers

Bills would create expedited pathway for certain biologics, require more FDA inspections overseas

NEW YORK — Legislation proposed in the House of Representatives would speed up Food and Drug Administration approval of knock-off versions of vaccines and other biologics while requiring the agency to conduct more inspections of drug factories overseas, according to published reports.

The Pittsburgh Post-Gazette reported that the bills, sponsored by Republican Rep. Tim Murphy of Pennsylvania, would create an expedited FDA approval pathway for follow-on versions of biogenetic medications such as vaccines and drugs made from human tissue and plasma.

According to the newspaper, Murphy said the legislation would make the medications more affordable and accessible while ensuring that offshore drug makers are held to the same manufacturing standards as those based in the United States.

The Post-Gazette reported that the House Energy and Commerce Committee passed the legislation 46-0 and now heads to the House floor.


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