NICE
NICE (National Institute for Health and Care Excellence) plays a central role in ensuring NHS patients gain access to effective treatments at a sustainable cost, and off‑patent medicines are an increasingly important part of that mission. Its remit is not limited to initial appraisal: NICE applies a whole‑life cycle approach, revisiting guidance as evidence evolves, market conditions shift and prices change. This dynamic process means that medicines once deemed unaffordable can be recommended when generic or biosimilar competition reduces costs.
NICE and biosimilars
NICE plays a pivotal role in supporting the adoption of biosimilars in the UK by ensuring they are evaluated and recommended within the same framework as their reference biologics. According to NICE's position statement, if guidance exists for a reference biological medicine, it also applies to its biosimilar counterpart.
This approach reinforces clinical confidence by affirming that biosimilars are expected to be just as safe and effective as the originator products. NICE's technology appraisal guidance often advises that, when multiple treatments are suitable, the least expensive option should be chosen – factoring in administration costs, dosage and product pricing. This frequently positions biosimilars as the preferred choice, helping the NHS achieve better value for money.
Beyond guidance, NICE's endorsement of biosimilars has helped normalise their use across the UK healthcare system. By treating biosimilars as distinct but equivalent medicines, NICE encourages prescribers to consider them without bias, promoting broader access to biologic therapies. This has been especially impactful in therapeutic areas like rheumatology and oncology, where biosimilars have enabled thousands of additional patients to receive treatment.
NICE's consistent messaging and integration of biosimilars into its appraisal processes have contributed to the UK's growing biosimilar market, aligning clinical practice with cost-effective prescribing strategies.
NICE and generics
NICE is also undertaking work with generic products. Very recently it updated its guidance on the prostate cancer drug abiraterone, which could help thousands of patients and save the NHS millions of pounds.
NICE has published final draft guidance recommending abiraterone and its generic variants, in combination with androgen deprivation therapy and prednisolone or prednisone, as an option for adults with newly diagnosed high-risk hormone‑sensitive metastatic prostate cancer.
The decision marks a significant shift from its 2021 guidance, which could not recommend abiraterone because, at the time, it did not represent value for money for the NHS. The availability of lower-cost generic versions prompted a re-evaluation, leading to the positive recommendation.
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