What are Biosimilars?
The European Medicines Agency defines a biosimilar as a biological medicine that is highly similar to another already approved biological medicine (the reference medicine).1
Biosimilars are approved against the same standards of pharmaceutical quality, safety and efficacy as biologicals.2
Biological medicines are proteins that are made using living systems such as animal cells and bacteria. As with other types of medicine, a new and original biological medicine has a regulated period of time during which it can be made available exclusively. Once this period is over, it becomes possible to develop and bring to market a biosimilar medicine of the original or ‘reference’ medicine.
Approved biosimilars have been through rigorous testing to show that they have no clinically meaningful differences from their reference medicines. They are also manufactured to the same meticulous standards to ensure consistent quality. In addition, post-approval, all biosimilars are subject to safety monitoring in the EU.
Where biosimilars differ from their reference medicines, however, is that they typically cost less. This gives them the potential to offer significant savings for healthcare systems globally. For example, according to research by the IMS Institute for Healthcare, biosimilars have the potential to save European healthcare systems around €15 billion in the four years between 2016 and 2020.3
What conditions can they treat?
Biosimilars can help people living with debilitating and life-threatening diseases, such as rheumatoid arthritis, psoriasis, and cancer.
Are Biosimilars authorised for use in Ireland?
Yes. Biosimilars have been authorised in Ireland since 2006 but despite the EMA granting market authorisation for 28 biosimilars, only 11 biosimilars were reimbursable by the State in 2017.4
The National Biosimilar Medicines Policy is currently being drafted by the Department of Health in anticipation of the expiration of a number of biological patents over the next few years. The policy will aim to increase biosimilar use in Ireland, by creating a robust framework in which biologicals and biosimilars can be safely, cost-effectively and confidently used in the health service.5
Is a biosimilar medicine as effective as the reference biological medicine?
Yes. A biosimilar medicine is tested to make sure it is as effective as the reference biological medicine.6
Is a biosimilar medicine as safe as the reference biological medicine?
Yes. A biosimilar medicine is tested to make sure it is as safe as the reference biological medicine. A biosimilar medicine should not have more side effects than its reference medicine.6
All medicines can have side effects. If you have any questions about side effects, talk to your doctor, nurse specialist or pharmacist.
Are there benefits to using Biosimilars?
Yes. Biological medicines have changed and improved the treatment of many serious diseases such as cancer. But biological medicines are usually very expensive. Biosimilar medicines encourage competition and may reduce the cost of biological medicines. This means that healthcare systems such as the HSE can save money and be more efficient. Reducing the cost of biological medicines can help free up resources for other important areas of healthcare.2