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October 17 | 9:00-10:30AM ET

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

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Learning objectives

At the conclusion of this session, participants should be able to:

  • Assess the potential for biosimilars in China
  • Explain the navigation of the Chinese regulatory system with respect to gaining biosimilar approval
  • Describe the design of a global clinical development program that meets the Chinese regulatory requirements

Program Committee

  • Leah  Christl, PhD
    Leah Christl, PhD Executive Director, Global Regulatory and R&D Policy
    Amgen, United States
  • Hillel  Cohen, PhD
    Hillel Cohen, PhD Executive Director, Scientific Affairs
    Sandoz Inc., United States
  • Thomas  Felix, MD
    Thomas Felix, MD Medical Director, R&D Policy, Global Regulatory Affairs and Safety
    Amgen Inc., United States
  • Julie  Marechal-Jamil, MSc
    Julie Marechal-Jamil, MSc Director, Biosimilar Policy & Science
    Medicines For Europe, Belgium
  • Laura  McKinley, PhD
    Laura McKinley, PhD Director, Global Regulatory Policy and Intelligence
    Pfizer Inc, United States
  • Cecil J. Nick, MS
    Cecil J. Nick, MS FTOPRA, Vice President (Technical)
    Parexel Consulting, United Kingdom
  • Jian  Wang, MD, PhD
    Jian Wang, MD, PhD Division Manager, Clinical Review Division – Heamatology/Oncology
    Health Canada, Canada
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Other Sessions

Session 1: Barriers to Uptake of Biosimilars in the US | On-Demand

Session 2: Biosimilar Reimbursement in the US Marketplace | On-Demand

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