Clinical Data Requirements for biosimilar registrations
March 22, 2019 8:38 am- 11:30-12:00: Comparative PK/PD
- 12:00-12:45: Phase 3 Safety and Efficacy
- Safety assessment
- Statistical consideration/ Historical data
- End points
- Safety of Biosimilars since first one launched in the EU
- 12:45-13:00: Discussion: Challenges & Opportunities in conducting clinical trials for biosimilars
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