Managed Entry

Biosimilars

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Biosimilar medicines are new biological medicinal products that have demonstrated ‘similar’ efficacy and safety to an existing biological reference (‘originator’) product.
 
The NI Managed Entry mechanism is based upon appraisal by recognised Health Technology Appraisal bodies e.g. NICE; SMC. The position of NICE in respect of biosimilars is set out at https://www.nice.org.uk/Media/Default/About/what-we-do/NICE-guidance/NICE-technology-appraisals/biosimilars-statement.pdf
Given this position, where the originator product has been accepted for use in Northern Ireland, any biosimilar medicine will generally be deemed ‘accepted for use’ in Northern Ireland also. However, each individual biosimilar medicine may not have its own entry on the Managed Entry web page
 
For example:
Lantus® (insulin glargine) is accepted for use in Northern Ireland. Abasaglar® is a biosimilar of insulin glargine and, although it is not specifically mentioned on the Managed Entry website, it is also accepted for use in Northern Ireland.
 
Please note: Biosimilar medicines should always be prescribed by brand name.