An Examination of the Regulatory and Reimbursement Processes for Biobetters and Comparison With Biosimilars.

new chemical drugs in Sweden. Recommendations were based on clinical comparability and lower drug acquisition costs, for the biosimilars versus the originator, and for lipegfilgrastim versus pegfilgrastim. Use of the pegylated forms of filgrastim appear to be restricted to certain situations where their use is considered appropriate. Wales:12 The biosimilars and the pegylated forms of filgrastim were recommended based on demonstration of clinical comparability to the respective comparator. Convenience with the use of the pegylated forms of filgrastim were additionally noted, and they were recommended for restricted use. A costminimisation analysis was provided for the biosimilars, while a cost-utility analysis and budget impact analysis were considered for pegfilgrastim. England:13 Filgrastims have not been appraised by the National Institute for Health and Care Excellence (NICE). To date, only one biosimilar product (somatropin; Omnitrope) has undergone HTA appraisal in England, with decisions on the use of biosimilars being made at a local payer level. NICE is expected to publish guidance on the appraisal of biosimilars shortly.