OBJECTIVES: The advent of biosimilars has significantly transformed the landscape of medicine because it offers patients access to high-cost biologics at a more affordable level. Unlike generics, biosimilars are not identical to its reference product. Hence, it is essential to develop guiding principles for evaluating biosimilars for formulary inclusion in the local context of KK Women’s and Children’s Hospital, Singapore.

METHODS: A literature review was conducted by Drug Information Services, Pharmacy to identify existing principles on selecting biosimilars by regulatory authorities e.g. US Food and Drug Administration (FDA), Singapore Health Sciences Authority (HSA) and Agency for Care Effectiveness (ACE) as well as other international healthcare institutions. The final draft was presented to the Pharmacy and Therapeutics (P & T) Committee for approval.

RESULTS: The backbone of the guiding principles applies to adults and paediatrics e.g. approval of the indications by local healthcare regulatory authorities, characteristics and immunogenicity of the biosimilars compared to the originator. Efficacy and safety studies in paediatrics must be considered as it cannot be extrapolated from adult data, due to differences in disease severity, pharmacokinetic and pharmacodynamic differences between the two populations. In addition, position statements by expert bodies should be reviewed, together with opinions of key stakeholders in the hospital and experience of use in other countries. This is important as biologics are usually last-line therapies in paediatrics, hence physicians may be cautious of starting it since there may be no further options in case of treatment failure. A detailed plan for introduction of biosimilars should be in place, which includes timeline, patient selection, educational materials and monitoring plans to track adverse events of the biosimilar.

CONCLUSIONS: These principles were formalized as a policy and procedure governing the inclusion of biosimilars into the hospital formulary, to maintain the balance between safety and cost-effectiveness of the biosimilars.