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  • Introduction-scene setting
  • Definition and features of biosimilars
  • Definition and features of biosimilars
  • Since 2006, the EU has approved over 30 biosimilar medicines and in the last 10 years these medicines have been used safely and effectively to treat patients with conditions such as arthritis, cancer, colitis, Crohn's disease, and psoriasis. 
  • How does EMA make sure biosimilars are safe and effective
  • Most medicines available today are made of small, chemically synthesised molecules. But increasingly biological medicines are being developed using cutting-edge biotechnology techniques, to offer new treatment options to patients with chronic and disabling conditions. Biological medicines come from cells and are made of biological material such as proteins or nucleic acids. They are much larger and more complex than small chemical molecule medicines.
  • Implication of availability of biosimilars-patient rep and patient
  • Interchangeability, switching and substitution-head of NCA
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