Biosimilar Clinical Trials: How Can Regulators Determine Waiver Early In Development?
The evidence is growing that comparative efficacy trials may not be necessary for all biosimilars, but regulators said they need a standard for sponsors to meet in order to waive them.
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That’s So 15 Years Ago: Biosimilar Advocates Press US FDA, Sponsors To Evolve Thinking, Streamline Development
Requirements should adjust to scientific advancement, rather than remain rooted in times when the FDA and sponsors were inexperienced dealing with the products, sponsors argue.
Rather than conduct most analytical characterization and non-clinical studies first, the hallmark of the US FDA approach, biosimilar sponsors are often initiating clinical trials about the same time.
OTBB Director Sarah Yim tells the Pink Sheet that FDA cannot make an official determination that biosimilar-to-biosimilar switches are acceptable, but the agency does think about how a product will be used in the market while assessing the application.