- When lower-cost versions of AbbVie's top-selling drug Humira launch in the U.S. in 2023, pharmacists will be able to swap at least one of them for the branded product without a specific prescription to do so.
- On Friday, Boeheringer Ingelheim, which had settled with AbbVie to allow market introduction of its biosimilar Cyltezo in July 2023, announced the Food and Drug Administration approved its drug as an "interchangeable" product. The status allows pharmacists to substitute it for Humira, making it more likely the drug will be used by patients over the branded version. Other approved biosimilars must be directly prescribed.
- Cyltezo is one of six biosimilars of Humira that have won FDA approval and the first to obtain interchangeable status. The five other manufacturers besides Boehringer Ingelheim have also settled with AbbVie for launch dates in 2023, as have three other developers with Humira biosimilars that are not yet approved in any form.
AbbVie earned $8.1 billion from U.S. sales of Humira over the first six months of 2021 and, at that rate, is set to make roughly $25 billion more before the first biosimilar copy, Amgen's Amjevita, launches on Jan. 31, 2023.
Other approved biosimilars from Merck & Co., Mylan, Novartis and Pfizer will follow over the rest of 2023, creating the kind of "patent cliff" that pharmaceutical companies work mightily to delay.
AbbVie's been successful in that regard, creating a wall of patents around Humira high enough that all six companies, plus Fresenius Kabi, Momenta Pharmaceuticals and Coherus BioSciences, were forced to settle with the pharmaceutical giant for 2023 launch dates.
Expected launch dates of Humira biosimilars
|Drugmaker(s)||Biosimilar approved in U.S.?||Expected launch date|
|Amgen||Yes, Amjevita||Jan. 31, 2023|
|Samsung Bioepis, Merck & Co.||Yes, Hadlima||June 30, 2023|
|Boehringer Ingelheim||Yes, Cyltezo||July 1, 2023|
|Mylan||Yes, Hulio||July 31, 2023|
|Fresenius Kabi||No||Sept. 30, 2023|
|Novartis||Yes, Hyrimoz||Sept. 30, 2023|
|Momenta Pharmaceuticals||No (development discontinued)||N/A; per settlement, Nov. 20, 2023|
|Pfizer||Yes, Abrilada||Nov. 20, 2023|
|Coherus BioSciences||No||Dec. 15, 2023|
All told, AbbVie filed more than 250 patent applications covering Humira, its manufacturing and its uses, securing grants for 130, according to an analysis by the advocacy group I-MAK.
While the patent protecting Humira's "composition of matter" — often viewed as the most important for a medicine — expired in 2016, the broader patent estate held by AbbVie has prevented competitors from launching until seven years later.
"They just couldn't litigate through it," Tahir Amin, an I-MAK co-founder, testified to the House Oversight and Reform Committee in May.
Indeed, the 2023 expected launch dates are many years after what AbbVie had estimated internally back in 2014, according to a report compiled by the committee.
Biosimilars to Humira launched in 2018 in Europe and have since wrested a majority share of the market from AbbVie, with prices falling substantially as a result, according to analysis by Bernstein, an investment firm.
The same future could await AbbVie in the U.S. in just over a year. But biosimilars are regulated differently in the U.S., with a two-tier system of first general approval and then interchangeable clearance.
To secure interchangeable status, biosimilar developers must submit to the FDA results from so-called switching studies, which evaluate patient responses when they switch between branded and biosimilar products. Boehringer did so, in a study called VOLTAIRE-X, but so far is the only one to secure such an approval from the FDA.
Cyltezo is only the second interchangeable biosimilar ever approved by the FDA, although the pathway has existed for a decade. As interchangeable status allows direct substitution of a lower-cost product, it's viewed as an important step for boosting uptake of biosimilars, adoption of which has generally been slow in the U.S.
The first biosimilar granted interchangeable status was Viatris and Biocon's Lantus biosimilar Semglee.