ViewPoints: Study delays undermine the biosimilar push, but Remsima overtakes Remicade in Norway – although at what cost (or price)?

As evidenced by events in the past week, any assessment of the developing biosimilars market requires conflicting headwinds – both in favour of biosimilar developers and against them – to be taken into account.

Amgen, competing alongside a raft of established pharma players, has confirmed a six-month delay to its Phase III study for biosimilar Herceptin, with Pfizer almost simultaneously confirming a five-month delay to its own project.

More positively, Norway continues to act as a flag bearer for biosimilar adoption in Europe, with the Norwegian Medicines Agency confirming to FirstWord that Remsima (developed by Celltrion and marketed in Norway by Orion Pharma) has now overtaken branded Remicade in terms of volume market share.

The reason for such a performance, however? – a notably lower price than biosimilar developers would ideally like to adopt.

Insight, Analysis & Opinion

Prior to announcing this delay to its Phase III biosimilar Herceptin (ABP 980) study, Amgen was viewed as the likely first-to-market player, remarks Duncan Emerton – editor of FirstView's Biosimilar Index, which tracked both this delay and a similar one for Pfizer's biosimilar Herceptin candidate (PF-05280014).

"Due to this delay, it's now less clear which company will be able to submit their application and/or gain approval first," adds Emerton, citing a three horse race between Amgen, Pfizer and the biosimilar Herceptin product being co-developed by Samsung Bioepsis and Merck & Co.

Roche has previously acknowledged that it will benefit from the delayed launch of biosimilar Herceptin products, citing patient recruitment issues as the primary reason for extended study timelines. Whether recruitment difficulties have caused these latest delays for Amgen and Pfizer is unclear, says Emerton, but this would represent a concerning trend for biosimilar developers if it is the case, he adds (ViewPoints: Is patient recruitment proving troublesome for biosimilar cancer therapy developers?).
The specificities of the Norwegian tender system make it difficult to ascertain whether rapid market share gain for Remsima can be replicated in other European territories. Hospira – which will market Remsima in most of the region's largest markets – has played down such a scenario, primarily as the biosimilar will be priced at a 20 percent to 30 percent discount to branded Remicade in these countries.

This is well below the 72 percent discount that Orion has allowed Remsima to be priced at in Norway, which in the grand scheme of things may remain a curious outlier if Hospira's vice president of biologics Paul Greenland is correct in his assertions about pan-European pricing.

That said, rapid adoption of Remsima in Norway is highlighting that lower pricing for biosimilars can overcome barriers to uptake. Steinar Madsen, director at the Norwegian Medicines Agency, is candid that usage of the biosimilar version has been directly driven by Orion's notably higher discount in 2015 versus the 39 percent discount Celltrion had offered last year. Compared to a peak volume share of around 30 percent achieved in the latter months of 2014, Remsima suddenly achieved a 44 percent share in February as the higher discount kicked in. A 51 percent share achieved in March confirms this trend, with a bullish Madsen anticipating "more or less a wipe-out" of branded Remicade by year end.

Recruitment of 300 patients for the NOR-SWITCH switching study (designed to evaluate patient switching between biosimilar and branded Remicade) should provide further motivation for biosimilar adoption, but for the time being at least, price is king in the Norwegian market.

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