A biosimilar medicine is a highly similar, but not identical, copy of an originator biologic 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 biologic counterpart because of the complex production process needed for these medicines. Like the 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 differences 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 medicine has to show that it is as 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.

While biosimilars have been used to treat cancer for many years, their use for people with inflammatory conditions like arthritis is relatively new in Ireland. However, this is changing as there is increasing availability of biosimilars for arthritis patients in Ireland.

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 advanced biologic medicines 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 biosimilar medicines 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 biologic (BVB), 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 arthritis patients these will be considered to be the best value treatments. Overall by carrying out the BVB process and its implementation by clinicians, this will lead to significant savings for the health service.

Read the HSE information for patients about the best value biologics, January 2020. 

 

New patients

From 1 February 2020, it is HSE policy that adult patients who are commencing treatment with two particular drugs will be prescribed a BVB medicine. A new patient is an adult, who has never been prescribed these treatments before, or has not received these medicines within the last six months.

 

Existing patients

There is currently no change for existing patients. They will continue to receive their medicine under the high tech arrangement from their community pharmacy.

However, according to HSE policy, when existing patients present for a repeat prescription for those two biological medicines, 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 after 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 biologic.

 

How are biosimilars administrated?

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 exactly the same way as originator biologic therapies.