For Abbvie, 2023 is Year Zero, the date fixed for the entry of Amgen’s biosimilar version of Humira. This sets Abbvie's agenda for the next five years, as well as tying it to an ambitious long-term forecast of the type that derailed Celgene just last week.
Simply to keep from going backwards, the strategy will require Abbvie’s oncology projects to more than triple in sales, while at least one replacement autoimmune R&D project will need to hit blockbuster numbers and a second crack the half-billion mark. Chief executive Rick Gonzalez says he is confident that the group can “grow through” the Humira expiry; the sellside and investors are not quite so sure.
Two more years
As it stands, Humira's ability to drive growth could face some constraints. European sales will top out this year as the EU patent falls in a little less than a year, allowing Amgen and others to market a biosimilar there.
|Humira sales in major markets ($bn)|
In the US, it is true that Humira will not suffer from direct biosimilar competition until 2023 thanks to the agreement reached with Amgen (Abbvie sets the date for cash cow slaughter, September 28, 2017). But new competitors are entering in autoimmune disease, most significantly in psoriasis, where four new agents have been launched in the past three years.
Thus, Abbvie will need its new oncology agents Imbruvica and Venclexta to pick up the slack, and they might well do that – the two together add more than $2.9bn in revenue between 2016 and 2020, according to EvaluatePharma’s consensus of sellside analysts. In total, the revenue contribution from non-Humira assets grows from $8.6bn to $13.5bn, edging up only marginally as a proportion of the total.
But the outlook contains some rather big ifs – namely, three products due to be launched in the 2018-19 window that Abbvie expects to become big contributors. Rova-T, the cancer agent bought with the $5.8bn acquisition of Stemcentrx, adds $1.5bn by 2022 in the consensus, and not only has it had a major clinical stumble readout of a key trial has been pushed back six months (Why the Rova-T delay is anything but irrelevant, October 30, 2017).
In the autoimmune space, risankizumab will be the third IL-23 in psoriasis and will need to work hard to meet its $623m forecast in 2022 (Psoriasis gets more crowded as risankizumab scores, October 27, 2017). Upadacitinib will need to hope that the safety worries overshadowing the Jak inhibitors do not lead to significant delays or outright discontinuation of work in rheumatoid arthritis – that project adds $1.2bn in 2022 (Abbvie’s Jak flashes a warning for the whole class, October 25, 2017).
Abbvie optimistically claims that Rova-T and risankizumab will achieve $5bn in sales by 2025 and upadacitinib $6.5bn, well above where the sellside stands.
Growing through or going backwards?
From a wider perspective, the bullish view of these pipeline assets is necessary to justify Mr Gonzalez's contention that Abbvie will be "growing through" the Humira patent cliff. A strategy update released last week alongside the company's third-quarter earnings report suggested $35bn of risk-adjusted non-Humira sales by 2025.
This would be some achievement, especially when added to the company's hope of managing post-exclusivity Humira erosion. And how those sales will evolve after the entry of Amgen’s Amjevita is very difficult to say.
European entry next year could provide some clues, but so far EU biosimilars have had stronger uptake than those in the US – Remicade has held on to significant market share thanks to aggressive pricing and long-term contracting, and perhaps Mr Gonzalez believes that Abbvie can repeat Johnson & Johnson’s feat.
Five years will allow biosimilar makers time to refine their launch strategies and be prepared to counter innovators – and of course it goes without saying that as an intravenous agent Remicade has points of leverage that a self-administered drug like Humira does not (Samsung leaps into its first US biosimilars battle, July 25, 2017).
Mr Gonzalez, speaking in his first earnings call after the Humira-Amjevita settlement was reached, stated last week: “Humira will maintain a strong market position with a manageable erosion curve” beyond the 2023 drop-dead date. Abbvie will need that and some other things to go right with its pipeline to meet some ambitious goals.