AbbVie fends off biosimilar challengers to Humira until 2023
The last major legal standoff for a Humira biosimilar ended in May 2019, when AbbVie and Boehringer Ingelheim announced the settlement of patent litigation over the date of U.S. entry for a copycat version of AbbVie's top-selling drug.
Boehringer can begin selling its biosimilar of Humira 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 arrived in 2018 in Europe, the deals reached in the U.S. give the large biotech more than three years of stateside exclusivity, staving off all entries until 2023.
Boehringer had previously voiced confidence in its legal battle for Cyltezo, telling BioPharma Dive in December 2018 the company was "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 legal moat it could use to defend against competitors.
Despite its effort, the German drugmaker wound up joining fellow biosimilar developers, including Amgen, Pfizer and Mylan, in settling for U.S. entry in 2023.
"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 to BioPharma Dive.
Boehringer 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||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 Sandoz||Yes, Hyrimoz||Sept. 30, 2023|
|Momenta||No||Nov. 20, 2023|
|Pfizer||Yes, Abrilada||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. In the spring of 2019, the agency finalized its guidance on achieving that designation, giving industry some clarity on the required studies.
Boehringer started an interchangeability study in 2017. 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 a drug 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 2019 statement.
Humira has made up more than 60% of AbbVie's revenue in recent years, posting just under $20 billion in global sales for 2018, for example.
Article top image credit: AbbVie media library