ViewPoints: AbbVie concedes biosimilar defeat in Europe by shoring up its US Humira empire
AbbVie's settlement with Biogen and Samsung Bioepis reinforces the likelihood that biosimilar versions of Humira will not reach the US market until 2023, but confirms biosimilar competition will launch in Europe later this year.
Partners Biogen and Samsung Bioepis announced a licensing agreement allowing them to launch Imraldi - their biosimilar version of AbbVie's Humira - in European markets from October 16 onwards. The deal, which settles all pending patent litigation between the parties, also allows for the launch of Imraldi in the US from June 30, 2023 onwards.
Why is this important?
AbbVie saw significant share price gains following a similar agreement with Amgen, which was announced in August.
A second deal reinforces the notion that AbbVie's patent estate for Humira in the US will delay biosimilar entrants for another five years. Based on the assumption that US Humira sales remain flat at 2017 levels over the next five years, the franchise will contribute cumulative sales of around $70 billion over this period.
At around $6 billion last year, ex-US sales of Humira were approximately half that recorded in the US market. Though the majority of this figure was generated in the EU and feedback from payers indicates that future availability of biosimilar Humira is already seen as a potential watershed for the European biosimilar market - see ViewPoints: European payers gear up for 2018's biosimilar windfall.
Unsurprisingly, given the outlay on Humira, payers in the EU5 are keen to get their hands on biosimilar versions, while the UK - which has led legal manoeuvres to overturn AbbVie's patent estate - will look to replicate the approach it has used with MabThera; since launching last year, biosimilar rituximab has assumed an 80 percent volume share of the market under NHS England - see ViewPoints: The UK proves its worth at the vanguard of European biosimilar policy making.
Likely retention of Humira exclusivity for another five years in the US is a timely boost for AbbVie given recent investor fallout stemming from negative cancer study results (ViewPoints: AbbVie blush/Stemcentrx flush).
However, that setback and today's announcement provide a reminder that despite Humira's cash cow status, the countdown to patent expiry and need to replace this franchise continues to edge nearer. Investors appear to have already set 2023 as D-day for Humira; shares were down marginally in response to Thursday's settlement with Biogen and Samsung Bioepis.