NHS Publishes Update on the Use of Biosimilars

The United Kingdom’s National Health Service (NHS) has published a new document for clinical and nonclinical stakeholders about the role of biosimilars in the healthcare system. The guidance document, says the NHS, is intended to support the safe, effective, consistent use of biologics, including biosimilars, to the benefit of patients.

In the document, the NHS explains that, by 2021, through the use of the best-value biologics, the NHS can save at least £400 million to £500 million (US $508 million to $635 million) per year. Maximizing the value of the medicines for which the NHS pays will allow the NHS to produce “much-needed headroom” for funding innovative treatments and improving pathways of care.

The guidance explains such concepts as the inherent variability in the structure of all biologics, the difference between generics and biosimilars, the extrapolation of indications, and the European approval pathway for biosimilars.

It also explains that in cases in which the nation’s health technology assessment body, the National Institute for Health and Care Excellence (NICE), has already recommended use of the reference product, the same guidance will typically apply to the biosimilar.

It also highlights the fact that prescribers can switch patients from the reference to a biosimilar, and the decision of which product to prescribe rests with the prescriber in consultation with the patient. “Biosimilar products are considered to be interchangeable with their reference product; which means a prescriber can choose the biosimilar medicine over the reference product (or vice versa) and expect to achieve the same clinical effect,” the guidance notes. Pharmacy-level substitution is not permitted without consultation with the prescriber for any type of biologic, including biosimilars.

In keeping with national guidance and EU law, all biologics should be prescribed by brand name, not by international nonproprietary name, it adds. This practice should ensure that unintended substitution does not take place. Any adverse event should be reported using the brand name and specific batch number. Brand and batch information should also be provided to patients when products are administered to help them to report any issues accurately.

The guidance document is an update to 2015 guidance on biosimilars, and it was prepared in partnership with such stakeholders as the Association of the British Pharmaceutical Industry, the British Biosimilars Association, NICE, and the National Rheumatoid Arthritis Society, among others.