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Biosimilar medicines

  • Interchangeability: Does your country have a legal arrangement in place such that once a biosimilar is approved in the EU (or through some other mechanism) it is interchangeable, which means the biosimilar can be used instead of its reference product (or vice versa) or one biosimilar can be replaced with another biosimilar of the same reference product? If so, please briefly describe the arrangement?
  • Substitution at point of issuing medicine: Can a pharmacist / dispenser substitute biological medicines with biosimilars at the point of dispensing (e.g., at a pharmacy/hospital)?
    • If so, is it a requirement of State-funded schemes / social health insurance reimbursement to substitute with the available medicine of lowest costs or medicines within a lower cost bracket? (i.e., only reimburse the preferred biosimilar)
    • If so, does the pharmacist/dispenser receive training or specific payment from the Government or insurer?                                                                                                                                                                                                                                       
  • Has the above approach encountered criticism in your country?
  • Influencing clinical prescribing of biosimilar medicines: How is this done (e.g., incentives as in Best Value Biologics Programme (BvB), described below)?
  • Broad process of choosing preferred biosimilars: What is the overall process to determine preferred biosimilars for prescribing over their reference biological medicine? For instance, what broad criteria are used, and what organisation has responsibility for this?
  • Response to the EMA September statement: Following the September statement from the European Medicines Agency (EMA) (presented below) on the interchangeability of biosimilars, is your country planning any changes to increase biosimilar penetration/uptake?
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