Steinar Madsen, Medical Director of the Norwegian Medicines Agency, began a 20m NOK ($3m) study in 2013 investigating the effect on switching Janssen’s monoclonal antibody Remicade (infliximab) with its cheaper copycat Remsima on user access and uptake.
Results are not expected until next year, but speaking at the CPhI Worldwide Pre-connect Congress in Madrid this week, Madsen said the study has been extended by 26 weeks due to Remsima being “so cheap, it is difficult to find patients still using Remicade.”
There will be “an almost total wipe-out of the originator drug by 2016,” he added, thanks to high discounts, switching occurring at the discretion of hospitals/physicians and increasing management involvement in biosimilar advocacy.
The first Norwegian tender of the rheumatoid arthritis biosimilar in early 2014 was at a 39% discount to the reference product and after a year Remsima had captured around 30% of the market share.
But a second tender in February 2015 brought a discount of 69%, leading to the medical directors of all four health regions in Norway to recommend switching, and six months on Remsima is the market leader with 79.9% of the market share, he told delegates.
Remsima is made by Korean firm Celltrion but marketed throughout Scandinavia by Orion Pharma.
“In all four Nordic countries the discount is the same but the market share differs dramatically,” Madsen said, attributing this to different levels of switching and management involvement in supporting biosimilars.
For example, in Denmark switching is recommended and there is a strong level of involvement by regulators and payers, and therefore Remsima has already all but wiped out Remicade with the biosimilar having a 96.2% market share.
But in Sweden, switching does occasionally take place but is not recommended and there is low management involvement, thus Remsima’s market share sits at just 9.4%.
The Interchangeability Myth
The switching of a biologic product with a biosimilar at a pharmacy level is currently a hot topic in the US, with the first recently launched biosimilar – Sandoz’s Zarxio – not deemed interchangeable by the US FDA with its reference product Neupogen.
The Agency is under pressure to release guidelines on this, but according to Madsen this is just another delay in bringing cheaper and greater access to biological products, being exacerbated by anti-biosimilar campaigns questioning the safety of switching.
“The big myth is that there is a gold standard but in fact all biological products are biosimilars,” he said. “Due to the nature of these products, every manufactured batch is different.”
Furthermore, he argued there is already a high safety record on switching based on the experience of biosimilars in Europe. “After nine years, no important problems have been discovered.”