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About Oncology Biosimilars
Development
Heritage of Innovation
Oncology Biosimilar ProductsSupport & ResourcesMaterialsVideos
DevelopmentCommitted to biosimilars

A rigorous process

The process for biosimilar medicine development involves rigorous analytical studies to establish a comprehensive understanding of the similarity of the biosimilar to the reference product. Assessments of toxicity and clinical studies are also used to further establish similarity. Ultimately, the goal is to demonstrate that there are no clinically meaningful differences between the reference product and the biosimilar based on the findings from all of these studies.1

Reference: 1. U.S. Food and Drug Administration. Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product. https://www.fda.gov/media/82647/download. Accessed April 2023.
PP-RIT-IRL-0049. Date of preparation May 2023

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Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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