STAT+: FDA strikes to ease path for biosimilars as Trump seeks to chop drug prices
WASHINGTON — The Trump administration introduced a draft framework Wednesday that officers say will velocity cheaper variations of biologic medicine to market with the purpose of constructing medication extra reasonably priced and accessible for sufferers.
The framework will shorten the trail for the Meals and Drug Administration to approve biosimilars, or copycat variations of biologic medicine, by decreasing the scientific requirements firms want to fulfill earlier than bringing the medicine to market.
That can reduce the price of creating biosimilars and the time wanted to approve them, FDA Commissioner Marty Makary mentioned at an announcement concerning the change. Makary mentioned the company plans to launch its closing steering on biosimilars in three to 6 months.
