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NICE Issues Update on Biosimilars

written by

Leukaemia Care, Charity

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Last week, the National Institute for Health and Care Excellence (NICE) issued an update on its policies regarding biosimilar medicines.

Biosimilar medicines are medicines that are intended to be similar to an existing biological medicine, a copy of the original biopharmaceutical products made by a different manufacturer following patent and exclusivity expiry on the original product.

Biological medicines are produced in or derived from living systems and are made up of proteins, sugars or nucleic acids. Examples of biological medicines include monoclonal antibodies such as rituximab, hormones such as erythropoietin or immunoglobulins like interferon. Due to the nature of biosimilars involving large, complex molecules biologic drugs cannot be reproduced exactly. In order to gain approval for use, biosimilar medicines have to be demonstrated to be as safe and effective as the original reference medicine.

Over the last decade there has been a massive rise in the number of biological medicines receiving regulatory approval, as such there should be a number of expiring patents in the next few years. Following the expiry of the patent biosimilar medicines may be marketed and sold, usually at a far lower price than the originator medicine. As such, biosimilars have the potential to offer the NHS huge cost savings due to their comparatively low prices. However, biosimilar medicines have the potential to cause huge issues unless they are of the same quality required of the original reference medicines.

With the future increase in biosimilar applications in mind NICE has updated its methods for providing guidance and advice, intending to ensure that biosimilars are as safe and effective as the reference medicine. NICE’s approach is to consider biosimilars in parallel with the reference products through a Multiple Technology Appraisal (MTA) to ensure biosimilars are therapeutically equivalent. Or where a review of the evidence is considered necessary, NICE may produce an ‘Evidence summary new medicine’.

Monica Izmajlowicz, Leukaemia CARE’s Chief Executive said: “The regulation of biosimilar medicines to ensure their safety and effectiveness is key and its importance will only increase as the availability of biosimilars increases. We welcome this improvement and clarification of the regulation of biosimilars, which we hope will ensure the approval of only high quality biosimilars. High quality biosimilars are to be welcomed, as they reduce costs and free up funds for other treatments.

We feel that a similar process needs to be put in place for generic medicines, to ensure that generic medicines, like biosimilars, must be therapeutically equivalent to their reference medicine to be licensed and marketed within England and Wales.”

To view the announcement, please click here