NHS Releases Biosimilars Guidance, Prohibits Automatic Substitution

Biosimilar News  •  Regulatory Guidances

On September 24, 2015, the United Kingdom’s National Health Service (NHS) released a biosimilars guidance document, available here. In it, the NHS bans automatic substitution of biosimilars, meaning that pharmacists may not switch between biosimilars and reference biologics, or between one biosimilar and another, without the consent of the prescribing physician. Physicians are permitted to switch their patients to biosimilars, provided “there are appropriate monitoring arrangements in place.”

In order to prevent accidental substitution, and to facilitate pharmacovigilance, the guidance also requires that physicians use the brand name when prescribing biologics and biosimilars. This differs from the established practice for small molecule drugs, where prescribers use the international non-proprietary name (INN) to facilitate generic substitution.

Download PDF

Tagged with 

Comments are closed.