OBJECTIVES: Although biosimilars have been authorized by the European Medicines Agency, the US Food and Drug Administration, and other regulatory agencies as a cost saving alternative to more expensive biologics, their uptake has been slow. We aimed to study the health technology assessment (HTA) and reimbursement processes of biosimilars across different markets.

METHODS: We examined the HTA review process of biosimilars in the UK, Canada, Australia, Germany, France, and other European countries by reviewing the guidelines and position statements issued by their respective national agencies.

RESULTS: This work noticed that HTA review process for biosimilars can vary considerably in the countries studied, given differing views on biological equivalence, importance of adverse events, comparability of resource use and relevance of reference product as comparator. In the UK, NICE reviews biosimilars in the context of a multiple technology appraisal along with their reference product and issues an evidence summary of the new medicine without any recommendations; SMC, however, does not review biosimilars when the reference product is approved for the same indication, in the same population, in other cases a full review is conducted. In Canada, CADTH has a tailored approach for the review of biosimilars with recommendations to switching for some biosimilars. PBAC in Australia recommends a minor submission to the new biosimilars without a need for any economic evaluation for the same indication, and it supports the biosimilar substitution at pharmacy level. Germany’s IQWiG does not assess biosimilars unless requested and has not made any recommendations regarding biosimilar substitution. HAS in France considers biosimilars as new drugs and a full review is required.

CONCLUSIONS: Given that views on biosimilars varied across the majority of countries considered, the requirement for full HTA and economic evaluation differed and consequently guidelines for use, substitution and interchangeability of biosimilars similarly varied.