Real-World Evidence Under Consideration For Use In Interchangeable Biosimilars Applications
US FDA research funded under BSUFA III will investigate what kind of safety data is needed for interchangeability. A demonstration project aimed at improving biosimilar product development efficiency and enhanced regulatory decision-making also will be part of the new regulatory science research program.
You may also be interested in...
With regulatory science research already funded for generic drugs and biosimilars, CDER Director Patrizia Cavazzoni wants a program for prescription drugs considered for the next user fee renewal.
As part of BsUFA III, the FDA has announced that it will be commencing its regulatory science research program, which will focus on advancing the development of interchangeable products and biosimilars.
The FDA had picked grantees for the initial round of biosimilar regulatory science research, but told them not to start major activities until the user fee reauthorization was assured. Congress now appears to have reached deal for a ‘practically clean’ reauthorization.