The Chinese biosimilar market is opening up with regulatory controls such as import tax on cancer drugs, and batch testing requirements of imported drugs recently having been abolished. Alongside this, the Chinese pharmaceutical regulatory system has undergone sweeping reforms in the past two years resulting in acceleration of clinical trial approvals from almost two years to two months and the potential for the acceptance of foreign data. As such, China is becoming an exciting market for biosimilars. Nevertheless, navigating the Chinese regulations and guidelines remains complex. This virtual session will delve into China’s biosimilar regulatory pathways and explore how to optimize global biosimilar development with inclusion of China as a target region.

Featured Topics

• Biosimilar Market in China
• The potential for biosimilars
• The changing regulatory environment
• Clearing regulatory and commercial hurdles
• Securing reimbursement
• Overall Regulatory Strategy
• Raising data standards and alignment with international requirements
• CTA process and timeline; 60 days CTA/IND approval
• MAA process and timeline
• China Regulatory Strategy for Biosimilar Development
• Review of existing guidelines including newly issued guidelines on biosimilar Avastin (bevacizumab) and Herceptin (Trastuzumab) clinical design and review considerations and the technical requirements of acceptance of foreign clinical data (draft)
• Phase 1 PK study requirements
• Phase 3 clinical trial requirements
• Immunogenicity data
• Sourcing reference drug