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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