Pharmacy group calls for insulin biosimilar name change
The UK’s association for clinical pharmacists has written to Sanofi calling for the company to “revisit” brand names for current and future biosimilar insulins.
The UKCPA Diabetes & Endocrine Committee said it had an issue over the naming of Insulin Lispro Sanofi® (insulin lispro 100 Units/mL) because it includes the drug’s generic name.
In a letter to the company, the group say: “The availability of an insulin in the UK, that is a combination of the word insulin alongside a generic name of the insulin will undoubtedly cause great confusion.”
However, in response, Sanofi said the brand name “specifically allows for differentiation” between its product, the reference brand and any other biosimilars and also called for a meeting withUKCPA to discuss the matter.
The letter was written by Philip Newland-Jones, Consultant Pharmacist Diabetes & Endocrinology, and Victoria Ruszala, Specialist Pharmacist Diabetes and Endocrinology.
They said: “The majority of prescribing in primary care is electronic, along with pharmacy dispensing systems, and electronic discharge summaries, therefore a key focus of insulin safety campaigns over the past 20 years has been the importance of clear brand prescribing of insulin, especially at the point of transfer of patient care. This is further emphasised by all current education packages for the safe use of insulin.”
Sanofi is acknowledged in the letter for its efforts in supporting Insulin Safety Week and for its recent advocacy for patient safety through the negotiations and uncertainty around Brexit.
The pharmacists conclude: “We ask for your help today to continue to be an advocate for patient safety both personally and as the figurehead for Sanofi UK, by revisiting the UK brand names for current and future Sanofi biosimilar insulins.”
Sanofi UK and Ireland has addressed the points raised in the letter in a statement:
“The safety of people living with diabetes is important to Sanofi and we are pleased that the UK Clinical Pharmacy Association (UKCPA) are taking an active interest in the introduction of biosimilar medicines into the NHS. In our view, any policy supporting the uptake of biosimilars should be underpinned by three overarching principles: conformity with patients’ therapeutic needs; physician as a decision-maker in agreement with the patient; and, a stringent regulatory pathway, including brand name prescribing for all biologics.
“The brand name Insulin Lispro Sanofi® (insulin lispro 100 Units/mL) has been approved by the European Medicines Agency (EMA) through the centralised procedure and is in line with article 20 of the EC Directive for naming a medicinal product. The use of Sanofi in the brand name specifically allows for differentiation between our product, the reference brand and any other biosimilars, thereby facilitating the Medicines and Healthcare Products Regulatory Agency (MHRA) guidance on adverse event reporting to be followed. The pack labelling also clearly states the full brand name to ensure that any potential prescribing and/or dispensing risk is minimised.
“Sanofi recognises the important role of pharmacy in delivering high-quality patient care and has requested a meeting to further discuss with the UKCPA how we can support them in ensuring that national guidance is followed at pharmacy level.”
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