In anticipation of increasing numbers of biosimilar medicines becoming available for use by the National Health Service (NHS) in the coming years as patent protection for various biological medicines nears expiry, the National Institute for Health and Care Excellence (NICE) has updated its position statement on the process for providing guidance and advice on biosimilar medicines.
NICE carries out technology appraisals on the use of new and existing medicines and treatments in England and Wales based on clinical and economic evidence. The outcome of NICE's technology appraisals are important to manufacturers as they are not only highly influential both in the UK and internationally, but the NHS is obliged to fund medicines and treatments recommended by NICE for use by the NHS. NICE also produces evidence summaries for new medicines and guidance on clinical practice.
A biosimilar medicine is a medicine that is similar to an existing biological medicine, which in turn are medicines made using a living organism such as bacteria or yeast. Due to the complex chemical structure of biological medicines, the reference biological medicine cannot be replicated exactly and additional steps are required to demonstrate that any differences between a biosimilar medicine and the reference biological medicine do not affect the safety, effectiveness or quality of the biosimilar.
The updated position statement confirms that NICE will usually assess biosimilar medicines in parallel with their reference product(s). NICE will also produce an evidence summary for a biosimilar medicine where necessary, referencing the brand names of the medicines and not just the name of the active drug substance, as substitutability and interchangeability between a biosimilar and the reference biological medicine is not automatic.
Further details and a copy of the guidance is available at:https://www.nice.org.uk/news/article/evaluating-biosimilar-medicines