Biosimilars and NICE
NICE (National Institute for Health and Care Excellence) plays a key 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. Biosimilars have been identified as one of eight priority health areas where NICE believes it can make the greatest impact on patient care and NHS resources in the year ahead.
Clinical confidence
NICE's approach reinforces clinical confidence by affirming that biosimilars are expected to be just as safe and effective as the originator products. Its 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.
Bevacizumab
A good recent example of NICE's approach in action is bevacizumab. NICE has recently published final draft guidance recommending bevacizumab with chemotherapy for people with metastatic colorectal cancer.
This is the first time NICE has been able to recommend bevacizumab for colorectal cancer, following the availability of lower-cost biosimilar versions of the medicine.
Around 35,000 people are diagnosed with colorectal cancer in England each year. Nearly 10,000 of those will have metastatic colorectal cancer, where the disease has spread to other parts of the body.
NICE previously could not recommend bevacizumab for colorectal cancer because the branded version of the medicine (Avastin) did not represent value for money for the NHS. However, the availability of more affordable biosimilar versions enabled NICE to conduct a new cost-effectiveness review.
This review was done under NICE's whole-lifecycle approach to guidance development. The evaluation tested a simplified process to develop the recommendation. NICE's whole-lifecycle approach reflects a commitment in the government's 10-year health plan to continuously review priority clinical pathways, ensuring patients receive the best possible care while the NHS spends wisely.