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.
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.
Information source: https://www.biopharmadive.com/news/abbvie-staves-off-6th-humira-biosimilar-in-us/541665/
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