The clinical development process of biosimilar medicines

This infographic highlights the strictly regulated biosimilar approval process, which assesses biosimilarity on the basis of the totality of evidence.

To maintain consistent product quality and activity, a biosimilar medicine must be made in accordance with good manufacturing practice for producing, processing, packaging, or storage of a drug product.1

The US FDA and EMA evaluate biosimilarity based on the totality of evidence versus the original-brand biologic. The totality of evidence includes assessment of all of a biosimilar’s chemical and clinical aspects compared with the reference biologic medicine.2,3

The clinical development process of biosimilar medicines

References:

1. FDA. CGMP regulations. Available at: https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations. [Last accessed April 2022].
2. FDA. Available at: https://www.fda.gov/files/drugs/published/FDA%E2%80%99s-Overview-of-the-Regulatory-Guidance-for-the-Development-and-Approval-of-Biosimilar-Products-in-the-US.pdf. [Last accessed April 2022].
3. EMA. Biosimilars in the EU. Available at: https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf. [Last accessed February 8 2022]

 

These materials are intended for healthcare professionals only. This page is sponsored by Sandoz.
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