Regulatory Approval Pathways | BioEngage from Amgen Biosimilars

Biosimilars require robust regulatory pathways

The biosimilar approval pathway requires the manufacturer to demonstrate similarity with the reference product for quality, safety and efficacy. Specifically, the biosimilar must demonstrate that it has no significant clinically meaningful differences to the reference product (1,2,3).

Explore all of our available resources for more information on the regulatory pathway for biosimilars.

References: 1. Markus et al. Developing the Totality of Evidence for Biosimilars: Regulatory Considerations and Building Confidence for the Healthcare Community. 2017. BioDrugs. 175-B-2; 176-B-3 2. United States Food and Drug Administration. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. 2015. 3. European Medicines Agency. Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues. 2014.