pharmabio consulting

Advancement of Biosimilars Development by Dr. Hoss A Dowlat

OBJECTIVES

  • Provide insight into what is meant by a biosimilar in medical practice based on EU experience 2006-present
  • Describe the EU approval precedents of biosimilars and EMA’s influence on the international WHO guidance and national guidances worldwide
  • Describe the unfolding and adoption of biosimilar pathways of approval by agencies in the rest of the world
  • Describe FDA’s independent position laying down the basis of approval of biosimilars
  • Describe the implications of biosimilars in medicinal therapy
  • Describe the developing roles and influence of stakeholders

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