On Friday AbbVie reported its Q4 2015 results, announcing net sales of its rheumatoid arthritis biologic of $3.7bn (€3.4bn) for the quarter, up 10.5% on the same period last year.
In the US – where there is no direct competition – Humira sales grew 20.7%, but reported international sales dropped 13%, though the firm attributed this to unfavourable exchange rates.
The report had been highly anticipated by biosimilar makers and analysts alike, with Evercore ISI’s Mark Schoenebaum saying there was concern about “the performance of Humira [adalimumab] ex-US, in light of investor concern after the weakness in the last few quarters, the ongoing launch of biosimilar Remicade [infliximab] in the EU, and the recent approval of the first Enbrel [etanercept] biosimilar in the EU.”
But management remained resolute it would not see significant biosimilar erosion of sales in the US thanks to its high level of confidence in its IP, as demonstrated by a recent rejection of Amgen’s inter partes review (IPR) challenge by the Patent Trial and Appeal Board.
Speaking on Amgen’s - and potentially other - IPR, CEO Richard Gonzalez told investors: “Across all of the litigation aspects of Humira, I think it's important to recognize that we have now entered a new phase of our biosimilar strategy.”
While he refused to comment more on future legal challenges, he said “the most important thing here is that we prevail… our responsibility is to make sure that we put the best position forward and that we don't tip off our opponents in this process as to what our strategy is.”
Gonzalez also said outside the US there would be some impact from Enbrel and Remicade biosimilars beginning this year, and direct competition would commence in the fourth quarter of 2018.
AbbVie also stands by there not being Humira biosimilar in the US until at least 2022, despite current consensus forecasting a “biosimilar Humira in the US launching in 2019,” according to Schoenebaum.
FDA Remicade panel
Management was also asked on the call about next week’s US FDA panel meeting looking to discuss Celltrion’s proposed biosimilar to J&J’s Remicade.
“We've been watching this play out in the international markets and studying it carefully,” Gonzalez said. “We're not seeing a direct impact on Humira… and so we wouldn't assume that there would be an impact in the United States either. It really fits in a different category.”
J&J’s infliximab was initially approved by the FDA in 1998 for the treatment of Crohn's disease but added other indications – including RA – for which the panel is likely to also recommend Celltrion’s biosimilar for due to data extrapolation, Gonzalez said.
“We don't agree with that. We think it's important for any drug to be tested in the indication that it's going to be used in and generate some clinical data. But I'd say we plan from a conservative standpoint that we will see extrapolation in all the major markets around the world.”