- AbbVie reached yet another deal with a rival to hold off the U.S. launch of a Humira biosimilar until 2023, the company announced Tuesday.
- In an agreement, Momenta Pharmaceuticals will pay AbbVie royalties for the right to launch its biologic copy of the world’s best-selling drug in the U.S. on Nov. 20, 2023. AbbVie said the Momenta’s launch date «will not be accelerated by the entry of companies who have already taken license.»
- Momenta is the sixth pharma to reach such an agreement with AbbVie. Further deal terms are confidential and were not disclosed by the companies.
While four biosimilars of Humira (adalimumab) launched two weeks ago in Europe, the U.S. market remains AbbVie’s for the foreseeable future.
Humira is not just AbbVie’s top product, making up more than 60% of the company’s total sales, but also the best-selling drug in the world.
In financials released last week, Humira sales were up 9% for the third quarter compared to a year ago, with $5.1 billion in sales from July through September.
To protect the biologic from competition, AbbVie has now successfully pursued deals with six pharmaceutical companies to push a U.S. launch date back several years. Those copycats have staggered launches for 2023, with Momenta now bringing up the rear.
Settlement deals keep Humira biosimilars at bay in U.S.
|Drugmaker||Biosimilar approved in the U.S.?||Expected launch date|
|Amgen||Yes, Amjevita||Jan. 31|
|Samsung Bioepis||No||June 30|
|Fresenius Kabi||No||Sept. 30, 2023|
|Novartis Sandoz||Yes, Hyrimoz||Sept. 30, 2023|
|Momenta||No||Nov. 20, 2023|
Notably absent from that list is Boehringer Ingelheim, which remains a rogue holdout still attempting to legally challenge AbbVie’s patent position. Boehringer’s version of Humira is approved in the U.S. under the brand name Cyltezo.
On AbbVie’s third quarter earnings call last week, CEO Rick Gonzalez expressed confidence in Humira’s position, using the string of 2023 deals as evidence of its strength.
«We have had very sophisticated companies that have made a decision based on our IP to do a settlement with us,» he said. «I think that speaks for itself.»
Momenta stated it plans to file an application with the Food and Drug Administration for its Humira biosimilar by the end of 2018 and with the European Medicines Agency in the first half of 2019. The agreement allows Momenta to launch its copycat drug in Europe once it is approved.
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