Viewpoints: Will Humira biosimilars launch in Europe this year?


Domininc Adair has been quoted by by First Word Pharma, a global leader in news and intelligence for the pharmaceutical industry, helping professionals stay up-to-date with the most relevant news, insights, analysis, and views from across the globe.

The biosimilars market continues to generate headlines, albeit for the impact these products are having on  branded biologics. Most recently, Roche reported a 25-percent decline in European MabThera sales during the  fourth quarter of 2017, a region where biosimilar rituximab competition is in full swing with the launch of Celltrion’s Truxima and Rixathon from Novartis’ Sandoz unit.

It’s the fortunes of AbbVie, however, which seem to be garnering the most interest ahead of a potential European debut for Humira biosimilars in the fourth quarter of 2018. Humira generated global sales of $18.4 billion in 2017, equal to 65 percent of AbbVie’s total revenues

can other Humira biosimilar developers ride on the coat tails of this judgement, or is it limited to FKB and Samsung only? Adair says that things are far from clear. “No-one knows for sure, but it’s more than likely. If another Humira biosimilar came along with the same label and wanted to rely on the judgment, the court would be very sympathetic to their cause if AbbVie refused to acknowledge that they were free to launch,” he noted. Adair continued by saying that “the declaration was given to FKB on the basis that their biosimilar product could not be caught by the Humira dosage regimen patents in suit in that case if the patents were also to be valid. If another Humira biosimilar with the same label – and hence the same dosage regimen – came along it would be very hard to stop.”

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Dominic Adair


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