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%
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