by Helen Collis
LONDON, Dec 11 (APM) - European patients treated with Remicade could be switched to the biosimilar based on the outcome of an ongoing ‘switching’ trial in Norway, opening up a potentially huge opportunity for forthcoming biosimilar launches to some of the biggest-selling drugs.
The independent biosimilar switching study is underway to assess the safety and efficacy of switching patients from Johnson & Johnson/Merck & Co’s rheumatoid arthritis blockbuster Remicade (infliximab) to the licensed biosimilar version, Hospira/Celltrion’s Inflectra/Remsima (infliximab).
Speaking to APM in a telephone interview, Paul Greenland, vice president of biologics at Hospira, said: “I think for the whole biosimilar industry this will be an important study. You can’t guarantee what the outcome will be but if it’s positive it will be very positive for the biosimilar industry, payers and patients across the EU.
“There’s also the chance that it may not be positive, but of course we don’t expect that based on preliminary switch data that has already been seen in the Inflectra development studies.”
He added: “I think the outcome will be eagerly anticipated by the payers and industry.”
According to the clinicaltrials.gov website, the government-funded NOR-SWITCH study began enrolment in October. It aims to switch 500 patients from Remicade to Remsima at the clinician level in a hospital setting and is recruiting patients across the approved indications: rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and chronic plaque psoriasis.
The primary outcome measure is occurrence of disease worsening over a 52 week period. Read-out is expected around May next year.
Speaking to APM in a telephone interview on Wednesday, Dr Steiner Madsen, medical director at the Norwegian Medicines Agency (NoMA), said drugs regulators across the world are eagerly watching the trial.
“There has been very large interest all over the world and I’m personally travelling around the world to talk about the Norway experience,” because at present, compared with the rest of western Europe, “Norway represents about two thirds of all western Europe’s experience with biosimilar infliximab - so we have significant experience.”
He said drugs regulators were particularly interested in two key concerns: switching to a biosimilar - as opposed to beginning first treatment with the copycat drug - and extrapolation of indications.
He said, already in Norway some hospitals have switched all their patients to the biosimilar version, “but some are waiting for the results of the switch study before, so they know that switching is absolutely safe”, he said.
“So the views on this study are also split in Norway - some physicians think it’s necessary to have to do switching immediately and some physicians say that it’s nice to have the study before we start switching.”
On extrapolation of indications, Madsen said the biosimilar was studied in rheumatoid arthritis (RA) and ankylosing spondylitis. He said questions have been raised by other regulators about the extrapolation of indication in inflammatory bowel diseases. He said, as far as he knew, just one gastroenteritis department in Norway is choosing not use the biosimilar in these indications.
Unlike generics, the biosimilar study is not looking at switching at the pharmacy interface, via automatic substitution. Madsen explained that in Norway, generic substitution does not exist, so this would be impossible to study.
He said, however, that the results of the switching study may influence regulators in European markets where generic substitution exists, to consider this pharmacy-level switching approach for biosimilars. "In other jurisdictions, this (study) might be used in this (automatic substitution) context."
Underlining the significance of the study, and the reason for so much interest, Madsen added: “The interesting thing will be how biosimilar infliximab will be received in the rest of Europe as the patent expires at the end of February next year.
“In my opinion that will be the acid test for biosimilars in principle. 2016 will be a very important year for biosimilars ... for the whole biosimilars principle.”
Biosimilar infliximab was approved in Norway in March 2013, but was not available until February 2014 after the manufacturer won a tender bid, with a 39% reduced price compared with Remicade.
Commenting on the price in Norway, Madsen said: “I think that (price reduction) is necessary. Biosimilars (companies) should, to have a rapid market share, have prepared a rebate in the range of about 40% (compared with the originator price).”
Previous estimates have been that biosimlars will be around 20-30% cheaper than the originator biologicals.
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