In anticipation of increased availability and demand for biosimilars in the National Health Service, England's health technology appraisal body has issued a position statement setting out how it intends to conduct assessments of biosimilars and issue guidance and advice on their use.
The National Institute for Health and Care Excellence (NICE) has said it will appraise novel biosimilars by way of a Multiple Technology Appraisal in parallel with the reference biological medicinal products in the indication under consideration. These Multiple Technology Appraisals will use the non-proprietary name of the active drug substance, including reference products and brand named biosimilars. If a product is recommended by NICE in a technology appraisal, the NHS is obliged to make it available for clinical use within 90 days. If further biosimilars for the same indication subsequently come to market, NICE will be entitled to apply any existing appraisals to those new products, if it sees fit to do so.
Where NICE considers that a review of the evidence for a novel biosimilar is necessary, it will consider producing an "Evidence summary new medicine". These evidence summaries will use only the brand names of the medicines because substitutability and interchangeability of different brands cannot be assumed. Evidence summaries will not make any clinical recommendations, meaning the decision regarding the choice of biosimilar or originator biologic for an individual patient would rest with the responsible clinician in consultation with the patient.
The standards which biosimilars must meet to be approved remain unchanged - they must demonstrate that they are at least as safe and effective as the originator medicine, and have at least the same quality. With cost pressures in the NHS at an all time high there will surely be a strong desire from clinicians and commissioners to see safe and affordable alternatives to proprietary biologics becoming available, and soon.