A biological medicine is a medicine that contains an active substance produced from a biological source (e.g. living cells). The active substance is the substance responsible for producing the therapeutic effect of the medicine. Examples of biological medicines include hormones (e.g. insulin for the treatment of diabetes) and monoclonal antibodies (targeted treatments for serious conditions, e.g. infliximab for the treatment of rheumatoid arthritis).
Biological medicines contain active substances which are larger and more complex than those of chemical (non-biological) medicines (e.g. paracetamol or aspirin). This complexity as well as the production methods used, means there is a natural variability in the molecules of the active substance. No two batches of biological medicine will be identical. Variability present between different batches of the same medicine must be kept within strict limits so as not to affect the safety and effectiveness of the medicine.
A biosimilar medicine is a biological medicine that is developed to be highly similar to an original biological medicine (known as the reference medicine) already approved for use in the EU.
Unlike chemical medicines, it may not be possible to produce an exact copy of an original biological medicine. The active substance of a biosimilar medicine and its reference medicine is essentially the same biological substance, though there may be minor differences due to its complex nature and production methods. Any differences between the reference medicine and the biosimilar medicine have been shown not to affect its quality, safety and effectiveness.
Like its reference medicine, the biosimilar medicine has a degree of natural variability. As for all biological medicines this is carefully controlled and monitored so as not to affect its safety or effectiveness.
A biosimilar medicine and its reference medicine will normally be administered the same way. A biosimilar medicine is generally used at the same dose to treat the same conditions as the reference medicine.
A biosimilar medicine can only be made available on the marketplace several years after the approval of the reference medicine. This is because the reference medicine benefits from a period of exclusivity, during which biosimilar versions cannot be marketed. Therefore biosimilar medicines will only be available for use when market exclusivity has expired for the reference medicine.
No. A biosimilar medicine is different from a generic medicine. The term generic medicine applies to chemical (non-biological) medicines e.g. aspirin and paracetamol. The active substance in a generic medicine is an exact copy of the active substance in its reference medicine. It may not be possible to make an exact copy of the active substance in a reference biological medicine owing to its complexity, natural variability and production methods.
No. A biosimilar medicine has been tested and has been shown to have comparable effectiveness to its reference medicine.
No. A biosimilar medicine has been tested and has been shown to have a comparable safety profile to its reference medicine, which includes the same level of side effects.
All medicines have the potential for side-effects. Talk to your doctor, nurse specialist or pharmacist if you have concerns about this.
No. As a biosimilar medicine is a biological medicine it must meet the same quality standards as all other biological medicines.
In Ireland biosimilar medicines are approved by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA).
During the approval process the biosimilar medicine is compared to its reference medicine to show that there are no clinically significant differences between them. Regulators apply stringent criteria in their evaluation of studies comparing the quality, safety and effectiveness of the new biosimilar medicine with the reference medicine
The studies on quality include a comprehensive comparison of the structure and biological activity of the active substances. The studies on safety and effectiveness are conducted in a specific disease setting(s) to show that there are no significant differences in the benefits and risks of the two medicines, including the risk of immune reactions (e.g. allergies).
As the reference medicine has already been authorised in the EU for several years and its clinical benefit and safety is established, some studies carried out with the reference medicine may not need to be repeated with the biosimilar medicine.
A list of all biosimilar medicines approved by the EMA can be found on the EMA website. Information on whether a medicine is a biosimilar medicine can be found in the medicine’s product information (under summary of product characteristics (SmPC)). Details of how the medicine was approved can also be found in the European public assessment report (EPAR). The product information and the EPAR for any medicine approved by the EMA can be found on the EMA website using the ‘Find medicine’ tab. Talk to your doctor, nurse specialist or pharmacist if you have any questions.
Yes. Biological medicines have revolutionised the treatment of many serious diseases such as cancer, diabetes and autoimmune conditions. However biological medicines are generally high cost and can have a significant impact on healthcare budgets. Biosimilar medicines can stimulate commercial competition which can reduce the costs associated with the use of these medicines. As such they have the potential to generate savings and efficiencies for healthcare systems, which can help free up resources for other important aspects of healthcare without compromising on effectiveness or safety. The availability of biosimilar medicines may increase patient access to medicines that may otherwise be unavailable to them.
Your doctor will decide this in consultation with you as the patient. If you are receiving a biological medicine for the first time you may be prescribed an original biological medicine or a biosimilar medicine if one is available.
In some cases the medicine you receive may change from a reference medicine to a biosimilar medicine or vice versa. This decision should be made by your doctor in consultation with you as the patient. Switching from a reference medicine to a biosimilar medicine or vice versa should not cause a change in treatment response. You should discuss any changes with your doctor, nurse specialist or pharmacist who will be able to answer your queries.
No. In Ireland a pharmacist cannot substitute a reference medicine with a biosimilar medicine or vice versa without the agreement of your doctor.
It is important you know the brand name of your medicine. This is because biological medicines with different brand names are not identical even when the name of the active substance is the same. Any decision to change the brand of your biological medicine should be made by your doctor in consultation with you. All medicines are supplied with a package leaflet. You should read the package leaflet that comes with your medicine as it contains important information for you. If you have any questions about your medicine speak to your doctor or pharmacist.
Suspected side effects of any medicine can be reported to your doctor, pharmacist or nurse. You can also report side effects directly to the HPRA. In the case of biological medicines this report should contain the brand name and batch number of the medicine. This information ensures that the report can be traced back to the correct medicine.