AbbVie's assertion that Humira will sail clear for several years gained strength on Thursday as the drugmaker inked a patent settlement with Amgen, holding off that company's biosimilar until 2023.
Under a new settlement, Amgen will have to wait until Jan. 31, 2023, to launch its Humira biosim, dubbed Amjevita, in the U.S. The biotech giant expects to launch in Europe next October, which could start to chip away at Humira's industry-leading sales. Still, some analysts and AbbVie executives think Humira will continue to climb from its perch of $16 billion in annual sales. Execs have thrown out $20 billion as their peak sales figure.
Amgen's settlement with AbbVie includes a patent license and royalties, and multiple analysts felt it provides clarity for AbbVie going forward as it looks to diversify past immunology giant Humira. Amgen won FDA approval for its biosim one year ago but hasn't been able to launch due to patent litigation; this deal clears that dispute. The settlement provides sales licenses on a worldwide, country-by-country basis, according to the Thursday statement.
Humira generated about $10.4 billion in the U.S. last year and $5.6 billion internationally for AbbVie, together representing 63% of the company's total sales. In a note, Jefferies analyst Jeffrey Holford wrote that the deal "increases visibility" for AbbVie as it transitions from "HumiraCo." to "NewCo." But even as the deal provides "incremental reassurance" of a Humira biosim launch date that's years off, Holford wrote, "there are many biosimilar developers and we expect 'noise' on this issue from time to time."
All along, AbbVie executives have said that Humira won't face competition in the U.S. until 2022 despite the fact that there are already two approved biosimilar versions. Besides Amgen, Boehringer Ingelheim has an approved copy; AbbVie has sued that drugmaker for patent infringement as well.
Thursday's deal has implications for other Humira biosimilar developers, too; if the legal experts at Amgen felt they could launch sooner based on weaknesses in Humira's intellectual property, they wouldn't have settled on 2023 in the key U.S. market.
Other companies with Humira biosims include Novartis’ Sandoz unit and Fujifilm Kyowa Kirin Biologics. Both of those versions have advanced to regulators in Europe, according to press releases, where Biogen also boasts an approval. Fresenius Kabi and Coherus have their own Humira biosims in development, too.
In a recent meeting with Leerink, AbbVie executives predicted Humira would peak at $20 billion in sales. To pad that haul, the company is hoping it can reach $4 to $5 billion in sales for each of two immunology candidates, upadacitinib and risankizumab, according to the analysts.
In hematology and oncology, the drugmaker is aiming for $10 to $12 billion in sales from Imbruvica and Venclexta, Leerink analysts wrote. Neurology, the third pillar of AbbVie's diversification strategy, should contribute in the middle of the next decade, execs said.
One big piece of news—which AbbVie denied—to come from Leerink's meeting is that executives reportedly told the analysts they were thinking about dropping the company's pricing pledge made by CEO Richard Gonzalez early this year. Their reasoning, according to the report, was that pricing pressure in the U.S. has waned. AbbVie later said the statements were mischaracterized and that it's sticking with the pricing pledge, at least for 2018.
When Humira suffers biosim erosion around the world per the new settlement, price hikes in the U.S. would likely play a role in the drug's overall sales performance for future years.