NICE Releases Updated Biosimilar Approach

February 11, 2015
BioPharm International Editors

The National Institute for Health and Care Excellence released an updated version of its biosimilar approach guidance, including increased consideration for technology appraisal, references in documentation, and the production of “evidence summaries”.

 

The National Institute for Health and Care Excellence (NICE) released an updated version of its biosimilar guidance. The amended approach will give more consideration to biosimilar medications, according to a press release. The guidance states that NICE will consider biosimilars recommended by the National Institute for Health Research Horizon Scanning Centre for referral to the technology appraisal selection process. A technology appraisal is the recommendation of new and existing medicines and treatments that is given to the National Health Service (NHS), this includes medicines, medical devices, diagnostics, surgical procedures, and health promotion activities. NHS is legally obliged to fund and resource medicines and treatments recommended by NICE’s technology appraisals, according to the NICE technology appraisal guidance.

The “biosimilars position statement describes NICE’s new approach to the biosimilar industry, including consideration for a review of similar biological medicinal product with the production of a “Evidence summary new medicine.” Because reference biological medicines and the biosimilars associated are not necessarily one and the same, NICE technology appraisals will use the name of the active drug substance when documenting reference products and brand-name biosimilars in order to maintain informed decision-making among patients and clinicians. Evidence summaries will use the brand name of the medicines to discourage recommendations, substitutability, and interchangeability.

Source:
NICELexology