Earlier this week the UK BioIndustry Association (BIA) and the Association of the British Pharmaceutical Industry (ABPI) launched a campaign to educate “prescribers and other stakeholders” in a bid to boost public understanding of biosimilars.
An ABPI spokesperson told BioPharma-reporter.com while there is clear MHRA guidance on biosimilars and the term is recognised in the clinical community the idea is to build on these foundations and underline some of the fundamentals.
“We will use our factsheets to engage with a clinical audience to enhance understanding and encourage appropriate use. Biosimilar medicines are different to conventional small molecule generic medicines and it is important that the clinical community fully understand the differences.”
One of the many points covered in the new factsheets is the naming of biosimilars, which has been a subject of heated debate among innovative drugmakers, generics firms and regulators for several years.
In the BIA and ABPI’s view “all biological medicines, including biosimilar medicines, should be prescribed by brand name, and not by International Non-Proprietary Names (INN), to ensure accurate reporting and analysis of suspected adverse reactions.”
The ABPI spokesperson explained that: “The use of the brand name ensures accurate tracking, reporting and analysis of suspected adverse reactions.
“Given the complexity of biological medicines and the fact that products from different manufacturers are similar but not identical; product-level traceability is extremely important for suspected adverse reaction reporting.”
The timing of these recommendations, which the groups say are also in keeping MHRA guidance and EU pharmacovigilance laws, coincides with heated debate about whether INNs should be common to both originator drugs and biosimilars.
Some argue that giving biosimilars the same INN as the originator could confuse prescribers, while others say the branded biopharmaceutical industry is trying to differentiate products in a bid to keep market share.
By advocating the use of brand names the BIA and ABPI are effectively aligning themselves with those groups calling for different INNs, however, the organisation rejected the suggestion the moves is intended to help members’ financial interests.
“If you look at the information presented in the factsheets it is clear that they are for education purposes to ultimately ensure these medicines are used appropriately for the benefit of all eligible NHS patients.
“This is an evolving field and it is important that, as representatives of the developers and manufacturers of these medicines, the ABPI and BIA can provide information to support their effective and safe use by the NHS.”