INN prescribing
Medicines UK supports the retention of brand names for biosimilars. We see this as vital to the long-term financial sustainability of the UK market and to ensuring patient support. While International Nonproprietary Name (INN) prescribing has been critical to the success of the generics market, we do not believe it should be applied to biosimilars.
Importance of brand names
The retention of brand names is essential for UK market attractiveness both at the launch and throughout the lifecycle of the medicine.
The R&D of biosimilar medicines is very different to that for generics in the scale of investment, taking up to nine years at a cost of up to £225 million.
Biosimilar development is at a global or regional (European) level, and manufacturing capacity is finite. Therefore, companies must choose carefully which national markets to prioritise and how much volume to supply to each one. We want the UK to be a priority market for both first launch in Europe and long-term supply.
By contrast, generic medicines may cost up to £5 million to develop, with R&D taking about three years. Generic medicines are typically most profitable for the manufacturer at launch on patent expiry. Intense competition makes that period short, with commoditisation within months. If the UK biosimilar market moves too far in this direction, then the UK will not be a priority market for manufacturers. This is because they will not be able to sell into the UK and recoup the far higher cost of biosimilar development.
Switching
Branding of biosimilar medicines assists rapid switching at the end of originator exclusivity, following patient consultation, since we believe it better supports patient acceptance.
Medicines UK believes that removing brand names would erode patient trust, making the switch more difficult, as it would hinder education of the equal value of originator biologics and biosimilars. This is reflected in feedback from some healthcare professionals attending an NHSE workshop on biosimilar education.
Removing brand names from biosimilars and related devices also creates a competitive advantage for originator products (which would retain more market share) and reduces the value of biosimilar brands.