Generic Vs Brand

Topic: Generic Vs. Brand Vs. Biosimilars Top 10 Generic Pharmaceutical Companies – many are branded companies, e.g., 1, 2, 3, 9, 10 1. Pfizer Established Pharma 2. Teva Generics (including Allergan Gx) 3. Sandoz / Novartis 4. Sun Pharma – Indian multinational pharmaceutical company 5. CR Pharmaceuticals – second largest distributor in Chinese pharmaceutical market 6. Yangtze River Pharma – Chinese multinational pharmaceutical corporation 7. Mylan – Morgantown 8. EMS – largest pharmaceutical company in Brazil 9. Abbott Established Pharma 10. Hengrui Therapeutics in Princeton, NJ = Jiangsu Hengrui Medicine Co. Ltd. Is largest ethical pharmaceutical company in China Effectiveness / Risk / Safety • Identical to brands • Possibly different fillers, color or shape Cost • First 6 months -- 10-15% discount • After 6 months -- >=70% discount Biosimilars • Highly similar, but not identical • No clinically meaningful differences in efficacy, safety, and potency vs. reference product • Reviewed and approved through an abbreviated FDA review process = 351(k) pathway • FDA guidance the Agency reviews the totality of evidence and does not necessarily focus on one type of study to evaluate a manufacturer's application for demonstration of biosimilarity • The manufacturer of a biosimilar demonstrates biosimilarity primarily from nonclinical analyses in a stepwise approach that includes examining the structure and functional nature of the biosimilar molecule Cost 1. Europe about 15% discount 2. US = 15% to 50% ______ Make sure to subscribe to get the latest episode. Contact Us: Email: [email protected] Website: http://www.propharmaconsultants.com/ Facebook: https://www.facebook.com/propharmainc Twitter: https://twitter.com/ProPharma/ Instagram: https://www.instagram.com/propharmainc/ LinkedIn: https://www.linkedin.com/company/pro-pharma-pharmaceutical-consultants-inc/ Podcast: https://anchor.fm/pro-pharma-talks YouTube: https://www.youtube.com/user/ProPharmaEducation