The rules ban “automatic substitution” for large molecule drugs – meaning pharmacists are not allowed to swap a biologic for a biosimilar (or a biosimilar with another biosimilar) unless the prescribing doctor tells them to.
But doctors retain the right to switch a patient’s medicine, providing “there are appropriate monitoring arrangements in place.”
NHS England also said doctors must prescribe biologics by brand name, and not by INN.
The rule will change the way doctors write their prescriptions. British medics are taught to prescribe using a medicine’s generic name or INN (international non-proprietary name). But in the UK, biosimilars use the same INN as their reference product.
To prevent accidental substitution, doctors in England will have to prescribe biologics – whether an originator or a biosimilar – using their brand name.
This approach is in line with EU law and recommendations from the MHRA (Medicines and Healthcare products Regulatory Agency) and NICE, the clinical standards authority for England and Wales.
The NHS said doctors should be aware of the “different requirements associated with biological medicines, including biosimilar medicines” and that they stick to pharmacovigilance monitoring requirements.
EU legislation requires all biologics approved since 2011, including biosimilars, to be labelled with a black inverted triangle (▼) which encourages doctors and patients to report suspected adverse drug reactions. The same applies to small molecule medicines with a newly approved API (active pharmaceutical ingredient).
The MHRA asks that ADR reports include the brand name and specific batch of the biologic.
Despite the precautions, the NHS said there are no reported cases so far where biosimilars have had safety problems which were different from the reference biologic.
The NHS defined a biosimilar as “highly similar to the originator biological medicine.”
“It must be shown to match or be highly similar to the key characteristics of the molecular structure and biological activity, and will be expected to have similar function and clinical outcome.
“Any differences will be expected to have no meaningful clinical impact on the safety and efficacy of the medicine for patients.”
The NHS document, ‘What is a Biosimilar Medicine?’ was welcomed by the Association of the British Pharmaceutical Industry (ABPI), the UK BioIndustry Association (BIA) and the British Generic Manufacturers Association (BGMA).
Warwick Smith, director general of the BGMA, said:
“In our view 2015 represents a breakthrough year for biosimilars which have the potential to offer the NHS considerable cost savings, especially as they are often used to treat long-term conditions. This will enable the NHS to treat more patients with these life-changing products.
“We strongly support NHS England’s efforts to ensure that balanced information and guidance is made available across the NHS to support the appropriate use of the growing number of biosimilar medicines in the best interests of patients.”