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General Guideline on Regulatory and Scientific Requirements for Development and Approval of Biosimilars

Activity start
10/11/2025
Activity end
09/01/2026
3
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The guideline provides an overview of the biosimilar protocol, reference product selection, the concept of the biosimilar comparison process, and the general regulatory and scientific requirements for the development and approval of biosimilars.
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Date of last update of page content: 12/03/2026at the hour 11:47 Saudi Arabia time