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A biosimilar medicine is a highly similar but not identical copy of an originator biological medicine. A biosimilar contains a version of an active substance of a biologic medicine, which is referred to as the ‘reference medicine’ or ‘originator medicine’.
A biosimilar medicine is not an exact copy of its biological counterpart because of the complex production process needed for these medicines. Like reference medicine, a biosimilar medicine has a degree of natural variability, due to the biological nature of its ingredients.
However, when approved for use in people by the European Medicines Agency, any difference between a biosimilar and its reference medicine will have been shown not to affect safety or effectiveness.
This means that in order to be licensed for use in people, a biosimilar has to show that it is safe and works as well as the originator medicine. All medicines, whether chemical or biological, have to be regulated for safety and approved before being made available to people.
Biosimilar infliximab was introduced in Ireland for IBD in 2014 and has been in widespread use in hospitals since then. Now, there is increasing availability of new biosimilars for patients with IBD in Ireland, including self-administered sub-cutaneous adalimumab. Biosimilar versions of other biologic drugs in IBD are likely to become available in the future.
Are biosimilar medicines the same as generic medicines?
No. Generics are small-molecule drugs made from synthesised chemicals that can be easily replicated, whereas biosimilars of biological medicine are much larger, complex molecules derived from living cells.
Biosimilars in Ireland
Since 2016 the HSE Medicines Management Programme (MMP) has supported the appropriate introduction of subcutaneous biosimilars into clinical use in Ireland to enable safe and effective prescribing, while also promoting cost-effective initiatives.
In 2018, the MMP started a process to evaluate therapeutic areas where there is potential for biosimilar medicines to be introduced to allow for their safe, effective and cost-effective use. In deciding on the best-value biological (BVB) medicine, the MMP invited submissions from all relevant stakeholders including clinicians, professional bodies and the pharmaceutical industry to the process.
What this means is that when clinicians look to prescribe treatments for patients with IBD these will be considered to be the best-value treatments. Overall by carrying out the BVB process and its implementation by clinicans, this will lead to significant savings for the health service.
From 1st February 2020, it is HSE policy that adult patients who are commencing treatment with adalimumab will be prescribed a BVB medicine. A new patient is an adult, who has never been prescribed treatments before, or has not received these medicines within the last six months.
There is currently no change for existing patients. They will continue to receive their medicines under the high tech arrangement from their pharmacy.
However, according to HSE policy, when existing patients present for a repeat prescription for adalimumab, the patient should be considered for switching to a BVB medicine. The decision to switch a patient to a biosimilar rests with the clinician; where it is clinically appropriate and in consultation with individual patients. Those that switch to a biosimilar are expected to have the same response as if they had stayed on the originator biological medicine.
How are biosimilars administered?
Generally biosimilars need to be given by infusion (intravenous or IV) in a hospital which may take several hours, or self-injected, using a needle and syringe or pen. This means, they are administered in the same way as originator biological medicines.