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Expectations for Biosimilar: An FDA Perspective 2016 GPA Biosimilar Council Conference North Bethesda, MD September 8, 2016, Steven Wazowski, M.D. Director, Office of Biotechnology Products OPQ/CDR/FDA
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Expectations for biosimilars refer to the requirements and standards set for the development, approval, and marketing of biosimilar products.
Manufacturers and developers of biosimilar products are required to file expectations for biosimilars.
Expectations for biosimilars can be filled out by submitting the necessary information and documentation as per the regulatory guidelines.
The purpose of expectations for biosimilars is to ensure the safety, efficacy, and quality of biosimilar products, and to provide regulatory guidance for their development and approval.
Information required on expectations for biosimilars may include data on the manufacturing process, analytical characterization, and clinical studies of the biosimilar product.
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