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AbbVie and Mylan reach US marketing agreement for Humira biosimilar

Published on 18/07/18 at 09:39am

AbbVie and Mylan have announced that they have both signed a licensing agreement for the former’s proposed biosimilar version of the latter’s Humira (adalimumab), a blockbuster with the reputation of the world’s best-selling drug.

As part of the deal, Mylan will be granted a non-exclusive license to market Humira in the US, beginning on 31 July 2023. No payment will be forthcoming from AbbVie, but Mylan will pay royalties to the drugmaker once its biosimilar is launched.

The agreement is designed to maintain sales of AbbVie’s biggest moneymaker until 2023, following the company’s signings of similar deals with Amgen last year and Samsung Bioepis earlier this year.

Humira is indicated in a range of diseases including rheumatoid, plaque and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease and ulcerative colitis. While the drug has a history as one of the industry’s biggest blockbusters, raking in two-thirds of AbbVie’s total revenue at $18.43 billion last year, its patent in the US market expired in 2016.

"AbbVie's Humira patents reflect the ground-breaking work of AbbVie scientists in the field of fully-human biologics and our investment in patient-focused innovation," said Laura Schumacher, Executive Vice President, External Affairs, General Counsel and Corporate Secretary at AbbVie.  "We understand the importance of balancing innovation and accessibility, and our agreement with Mylan for its Humira biosimilar maintains that balance."

Matt Fellows

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