Biologics: Reference Medicines and Biosimilars
An introduction to biologics and biosimilars, their similarities and respective roles in the treatment pathway.
The Biosimilar Clinical Development Process
An introduction to the key steps in the biosimilar development process.
The main goal in biosimilar development is to confirm that a proposed biosimilar and its existing biologic match in terms of quality, safety, and efficacy.1,2 Regulatory pathways for a biosimilar development program are stringent and include a stepwise comparability exercise of the proposed biosimilar to its original-brand biologic.1
References:
1. European Medicines Agency. Available at: https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf. Last accessed April 2022.
2. European Commission. Available at: https://www.medicinesforeurope.com/wp-content/uploads/2016/03/biosimilars_report_en.pdf. Last accessed April 2022.
These materials are intended for healthcare professionals only. This page is sponsored by Sandoz. MLR: 215945
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Biosimilar medicines clinical development process quiz
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