9 slides from Teva Pharmaceutical Industries's technical presentation, Nov 3, 2010
Slide 1: Biosimilars in the U.S. – Teva's Position on Key Issues
GlobalDevelopment Brandedof Products Biosimilars in the U.S. – Teva’s Position on Key Issues Rivka Riven-Kreitman, Ph.D., Senior Vice President, Q2-2010 Results Analysis Innovative Research and Development, Global Branded Products Teva Pharmaceuticals
Slide 2: Forward-looking statements
Forward-looking statements TODAY’S PRESENTATION CONTAINS FORWARD-LOOKING STATEMENTS, WHICH EXPRESS THE CURRENT BELIEFS AND EXPECTATIONS OF MANAGEMENT. SUCH STATEMENTS INVOLVE A NUMBER OF KNOWN AND UNKNOWN RISKS AND UNCERTAINTIES THAT COULD CAUSE OUR FUTURE RESULTS, PERFORMANCE OR ACHIEVEMENTS TO DIF
Slide 3: A Decade Long Commitment to Biosimilars
A Decade Long Commitment to Biosimilars • Teva is the world’s largest generic company and the 11th largest global pharmaceutical company • Over the last 10 years, Teva invested heavily in biosimilars: – establishing R&D and manufacturing infrastructure – acquiring technologies – developing partnersh
Slide 4: Biosimilar Development Pathway in the U.S.
Biosimilar Development Pathway in the U.S. • We consider the establishment of a biosimilar pathway in the U.S. an important initiative that could: – improve access to these highly expensive drugs – reduce the economic burden biotech drugs currently pose on the US healthcare system (expected to excee
Slide 5: Balanced Approach to Developing Biosimilars
Balanced Approach to Developing Biosimilars • When determining the requirements for the establishment of biosimilarity, Teva believes that a balanced approach is needed: – On the one hand, the complex nature of biologics warrants a cautious approach, and solid clinical evidence of similarity is need
Slide 6: Quality
Quality • Quality standards for biosimilars should be set at the highest level • Reference product should be thoroughly characterized and the biosimilar should be developed to be within the variability range of the reference product Teva Pharmaceuticals
Slide 7: Clinical Trials / Extrapolation
Clinical Trials / Extrapolation • Any biosimilar development program should include a robust pivotal clinical trial in one indication which will demonstrate similarity to the innovator's reference product in terms of safety and efficacy • Once biosimilarity has been established in one indication, th
Slide 8: INN / Reference Product
INN / Reference Product • The biosimilar products should have the same INN name as the innovator, and be differentiated only by its trade name • In order to avoid unnecessary replication of clinical trials, documented evidence or data generated in studies using innovator’s reference product in one r
Slide 9: Post Marketing Studies / Interchangeability
Post Marketing Studies / Interchangeability • Post marketing studies may be justified when there is a scientific rationale and a clear safety or efficacy need • Interchangeability should be allowed, once biosimilarity has been established following a development program which included a robust pivot