As reported by Regulatory Focus, Biosimilar experts from across the EU continue to show how rapidly biosimilars have gained market share, in contrast to US and Canadian markets. In particular, comments from the 16th annual Biosimilar Medicines Conference in London are instructive for industry to review.
Conference Comments
Regulatory Focus first quotes Keith Ridge, the chief pharmaceutical officer at NHS England. He told attendees that “the UK has seen increasing uptake of rituximab, infliximab and etanercept biosimilars, particularly in London. For instance, a biosimilar for infliximab, which came to market in March 2015 is now used by about 80% of patients on the medicine in the UK.”
He noted that the incoming Humira (adalimumab) biosimilars, which are hitting the UK market this autumn, will save the country £100 million ($140 million) per year. In the US, by contrast, adalimumab biosimilars are expected in 2023.
Justin Stebbing, professor of medicine at Imperial College London, questioned if companies moving forward will have to run the types of large clinical studies currently needed to further prove how biosimilars are comparable to their reference products. He predicted that in two years’ time, such clinical studies may not be run, barring an unforeseen “nasty event” that results in a biosimilar being pulled from the EU market.
Gustaf Befrits, a health economist with the Stockholm County Council in Sweden, noted that all the patients taking infliximab in Stockholm were switched to a lower-cost biosimilar in just two months, and very few expressed a negative opinion of the switch, though all patients were informed of the decision.
As pointed out in the Regulatory Focus piece, a review study published last month, cited at the conference, noted that data on biosimilars to date suggest that switching from a reference product to a biosimilar “is not inherently dangerous, and that patients, healthcare professionals, and the public should not assume that it is problematic.”
The article cites predictions that discounts in the EU between 25% and 70% off the original list price will be common and result in “significant volume increases.” The issues of safety, switching and extrapolation – all of which were question marks when biosimilars first came to market in the EU 12 years ago – “will largely be gone.”
In the US, meanwhile, savings from biosimilars over the next decade are expected to amount to more than $50 billion, but FDA approval does not mean market access and questions continue to linger with education and disputing anti-biosimilar rhetoric.