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Understanding biosimilars: An introduction for clinical trial investigators

Clinical trials are needed to bring these vitally important medications to market and participation provides opportunities for all enrolled patients to receive active biologic therapy. If you are considering participation or have already been selected to participate in a biosimilar trial, we encourage investigators and their site staff to take 30 minutes to find answers to the most commonly asked questions about biosimilars.

  • Biologics: Why is the current situation unsustainable?
  • What are biosimilars and how do they differ from generics?
  • What are the regulatory requirements for development of biosimilars and where have they been approved for use?
  • What are the potential benefits of biosimilars?
  • What impact could biosimilars have in key therapy areas?
  • Why should investigators and patients participate in biosimilar trials?