AbbVie settles one of its final Humira biosimilar suits for another mid-2023 delayed entry
AbbVie’s blockbuster rheumatoid arthritis drug Humira will see even more competition next year, as AbbVie and biosimilar developer Alvotech settled a court dispute over when the company’s adalimumab biosimilar can launch, even as the drug has yet to be approved by the FDA.
The settlement fully resolves all pending legal US disputes between AbbVie and Alvotech related to the biosimilar, which removes any barriers blocking Alvotech’s high-concentration version of adalimumab from reaching US patients on July 1, 2023.
Alvotech recently applied for an interchangeability designation where, if it won, would allow switching from the brand to the biosimilar without a doctor’s prescription. It would also put the company on par with Boehringer Ingelheim, which also has an interchangeability designation, and allow for a a July 1 launch date (but not the higher concentration) for its Humira competitor, known as Cyltezo.
But it’s going to be a crowded field, with as many as 10 biosimilars launching next year, all of which have been delayed by settlements similar to this latest one with Alvotech. The FDA approved the first biosimilar for Humira in 2016.
Amgen will be the first to launch its biosimilar in late January 2023, then Samsung and Organon will launch in late June 2023. The latter pair just submitted in January an sBLA for a citrate-free, high-concentration (100 mg/mL) formulation of its biosimilar candidate referencing Humira.
According to Wall Street biotech analyst Ronny Gal from Bernstein, nearly all of the incoming Humira biosimilars will offer the citrate-free version, although there’s more of a mix when it comes to which competitors will also be high-concentration, or have interchangeability.
Who is competing in the Humira biosimilar market? About ten developers are working on US launch of biosimilars for Humira (~$18B). The products differ based on interchangeability, concentration, and other features. pic.twitter.com/whOvuhFFVB
— Ronny Gal (@rgalBernstein) January 25, 2022
AbbVie has signaled that it expects about 45% erosion of its Humira franchise in 2023, and management has indicated that interchangeable biosimilars will have some impact on pricing as two interchangeable biosimilars were baked into AbbVie’s guidance.
But the US is unlikely to see some of the major landscape shifts seen in Europe when Humira biosimilars first rolled out there in 2018.
A JAMA paper on Denmark’s experience with Humira biosimilars showed a complete shift to the AbbVie competitors immediately after the patent expiration of Humira in October 2018.
“The proportion of adalimumab biosimilars increased from 71.6% (7040 of 9829 pens) in November 2018 to 95.1% (8974 of 9438 pens) in December 2018. Costs of adalimumab decreased by 82.8% from September 2018 to December 2018,” the study found.