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Episode 12 - What's Holding Back Biosimilars with Erica Gray, Pharm. D.

Episode 12 - What's Holding Back Biosimilars with Erica Gray, Pharm. D.

Biologic medications are some of the most innovative drugs on the market and some of the most expensive. In their place, biosimilar medications promise to make the treatment benefits of biologic drugs more accessible. While biosimilars bear no significant clinical difference to their biologic counterparts and face rigorous FDA approval pathways, biosimilars lack utilization, lack confidence from healthcare providers and patients, and struggle to come to market due to innovator biologic patents. Erica Gray of the Diamond Drug Information Center joins us to break down these factors and to give us a better understanding of just what is holding back biosimilars. Links to the material discussed in this episode: Biological Product Definitions. Available at: https://www.fda.gov/media/108557/download "Five things to know about biosimilars right now"- McKinsey & Company Available at https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/five-things-to-know-about-biosimilars-right-now "FAILURE TO LAUNCH: Barriers to Biosimilar Market Adoption" - Biosimilars Council Available at https://www.biosimilarscouncil.org/wp-content/uploads/2019/09/AAM-Biosimilars-Council-Failure-to-Launch-2-web.pdf "Biologics and Biosimilars: Background and Key Issues" - Congressional Research Service Available at https://fas.org/sgp/crs/misc/R44620.pdf "How logically impossible patents block biosimilars" - Nature Biotechnology Available at https://www.nature.com/articles/s41587-019-0196-x "Non-pharmacological Effects in Switching Medication: The Nocebo Effect in Switching from Originator to Biosimilar Agent." - BioDrugs. Available at https://www.ncbi.nlm.nih.gov/pubmed/30269270: Purple Book: Database of Licensed Biological Products. Available at: https://purplebooksearch.fda.gov/ US Food & Drug Administration. Patient Materials. Available at: https://www.fda.gov/drugs/biosimilars/patient-materials

Duration: 40 min

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