DTB: Vol 23, No 3

Biosimilar drugs Concept, regulation and controversies

Biosimilar drugs are developed according to established and specific requirements from the EMA and have proven similar efficacy, quality and safety compared to reference drugs. They have cost-saving potential that can contribute to the sustainability of health care. Concerns raised on the use of a biosimilar drug are the same as those with the corresponding original drug. Head-to-head clinical trials and post-authorisation studies are carried out to clarify any concern.


  • Beatriz Larráyoz. Hospital Pharmacist, Navarre Hospital Complex. Navarre Health Service, Spain
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