- The last major legal standoff for a Humira biosimilar has ended, as AbbVie and Boehringer Ingelheim announced Tuesday a settlement of patent litigation over the U.S. entry date.
- Boehringer can begin selling its copycat of the world's best-selling drug on July 1, 2023, paying royalties to AbbVie for the U.S. license, according to the settlement.
- Eight companies have now settled with AbbVie over Humira biosimilars. While Humira competition started this year in Europe, the deals reached in the U.S. give the giant biotech more than three years of stateside exclusivity, staving off all entries until 2023.
Boehringer previously voiced confidence in its legal battle for Cyltezo (adalimumab-adbm), telling BioPharma Dive last December the company is "committed to making it available to U.S. patients as soon as possible and certainly before 2023."
The pharma raised an "unclean hands" argument against AbbVie, alleging the biotech pursued overlapping patents to build a thicket it could use to wield off competitors.
As its legal defense carried on, the German drugmaker wound up joining fellow biosimilar developers, including Amgen, Pfizer and Mylan, in settling for U.S. entry in 2023 after all.
"We had hoped that litigation was going to make Cyltezo available sooner, however with the inherent unpredictability of litigation, the substantial costs of what would have been a long and complicated legal process and ongoing distraction to our business, we have concluded that this settlement is the best solution," a Boehringer spokesperson wrote in an email to BioPharma Dive.
BI joins its peers with a 2023 U.S. entry date
|Drugmaker||Biosimilar approved in the U.S.?||Expected launch date|
|Amgen||Yes, Amjevita||Jan. 31, 2023|
|Samsung Bioepis||No||June 30, 2023|
|Boehringer Ingelheim||Yes, Cyltezo||July 1, 2023|
|Mylan||No||July 31, 2023|
|Fresenius Kabi||No||Sept. 30, 2023|
|Novartis Sandoz||Yes, Hyrimoz||Sept. 30, 2023|
|Momenta||No||Nov. 20, 2023|
|Pfizer||No||Nov. 20, 2023|
As a silver lining, Boehringer wound up on the earlier end of 2023 entry dates, giving it a bit of an edge over several other biosimilars. Amgen is set to launch first, with the ability to do so as early as Jan. 31, 2023.
Boehringer may also score an advantage if it can become the first U.S. biosimilar to secure Food and Drug Administration's interchangeable indication. Last week, the agency finalized its guidance on achieving that designation, giving industry some clarity on the required studies.
Boehringer started an interchangeability study in 2017, which is expected to readout later this year. A company spokesperson called interchangeability "the catalyst for automatic substitution at the pharmacy level."
Wrangling the rogue holdout into a settlement clears AbbVie's potential risk for an earlier-than-expected launch for the biologic that is critical to the biotech's business.
"This is an important settlement as it resolves all Humira-related patent litigation in the U.S. and provides access for another biosimilar manufacturer seeking to enter the U.S.," said Laura Schumacher, AbbVie's chief legal officer, in a May 14 statement.
Humira (adalimumab) has made up more than 60% of AbbVie's revenue in each of the past few years, posting just under $20 billion in global sales for 2018.
But the first three months of 2019 started to show the effect of biosimilars. Even in just the first months of European entry, total sales fell 6% compared to the same period a year ago. European sales for the branded biologic dropped by more than 25%.
Humira biosimilars captured 15% of the European market in February, the fourth month since launching, Bernstein analyst Ronny Gal wrote in a recent research note. Gal predicted that biosimilars growing to take 50% of the Humira market in Europe within a year remains a possibility.