BsUFA III Talks Begin With Regulatory Science Disagreement
Brand trade group negotiators don’t support a biosimilar regulatory science proposal from the biosimilar and generic drug trade groups.
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Real-World Evidence Under Consideration For Use In Interchangeable Biosimilar 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.
US Biosimilars Will Get Regulatory Science Program, Supplement Timeline Changes In Next User Fee Agreement
Talks are completed, leaving only the generic drug user fee reauthorization negotiations ongoing.
Could US FDA User Fee Bill Include The Long-Sought 505(b)(2) Pathway For Biosimilars?
Former FDA official says the pathway is needed to avoid wasted sponsor time and effort.