Royal Pharmaceutical Society

Biologics and biosimilars – what are they?

By Jayne Lawrence, Head of Division of Pharmacy and Optometry, University of Manchester.

The Commissioning Framework for Biological Medicines announced recently by NHS England will both help guide improvements to developing better medicines for patients and provide a guide to ensuring the NHS gets best value for money from these innovative, exciting medicines.

What is a biologic?
Biological medicines have made many new, groundbreaking treatments possible, significantly improving the lives of many patients with long term conditions such as diabetes, arthritis, anaemia associated with chronic kidney failure, and types of cancer.

They are extremely expensive, in part due to the complexity of their production. For example, a course of a new immunotherapy drug typically costs more than £100,000 per patient per year. Furthermore, as biologicals currently comprise approximately 50% of all new drug approvals, it is likely that the high cost of new medicines is with us for the foreseeable future. Consequently, any way of reducing the cost of these important medicines is vital.

What is a biosimilar?
A biosimilar is a medicine intended to do the same job of as a biological medicine. In basic terms it could be described as the biological equivalent of a generic version of a conventional medicine. In contrast to a generic, a biosimilar is produced from a biological source and cannot therefore be an exact chemical copy. Biosimilars have demonstrated the same efficacy and same high levels of safety and quality as the originator biological.

Are biosimilars cheaper?
Biosimilars are currently achieving savings in the order of 25-50% of the biological originator. The reduced costs associated with the use of a biosimilar compared to their biological originator means that it will be possible to free up money for drugs in the system to treat more patients, which can only be a good thing.

In this context, it must be stressed that while a biosimilar is cheaper it does not mean that it is inferior to the originator product as it has been demonstrated to exhibit the same efficacy and same high levels of safety and quality.

How will patients know if they are taking a biologic or biosimilar?
If a clinician decides to switch treatment from a biologic to a biosimilar, the patient will be consult-ed so that they are fully informed and involved in this decision making process. In the case of any switch, the patient will be monitored as an extra precaution. It is not expected that any significant effects will occur, it is just a precaution as biosimilars are relatively new medicines and with any new drugs there is increased monitoring when it they are first used in practice.

From a patient’s perspective, unless they are being switched from the parent biological to a bio-similar, they might not realise that they are even receiving a biosimilar, as all biosimilars (and originator biological) will be prescribed by brand name. If a patient is receiving their medication from a community pharmacist (as would be the case with insulin glargine) then they should be prepared to be asked if they are getting the brand they were expecting. If they are not getting the brand they were expecting, the pharmacist can help.

What should you do if you have any concerns?
If a patient believes they are experiencing an adverse effect to any biological, biosimilar (or any medicine) they are taking should contact the prescribing clinician or their pharmacist for advice as well as reporting the adverse effect to the regulatory authorities under the MHRA's Yellow card scheme.


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