5 June 2019 - 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.