How Star Wars Explains Biosimilar Labeling Problems
US FDA largely writes biosimilar labels that are the same as their reference products even though it’s not required, which could hinder product development and uptake, experts say.
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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.
OTBB head Sarah Yim says FDA internal thinking is not aligned on the idea and that a lot of convincing was necessary to drop the clinical study requirement for insulin biosimilars.
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.