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AbbVie, Mylan enter patent license agreement for biosimilar adalimumab product
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AbbVie has entered a patent license agreement with Mylan regarding its proposed biosimilar adalimumab product, according to a press release.
Under the agreement, Mylan will get a nonexclusive license to AbbVie’s intellectual property related to Humira in the United States and other countries, excluding Europe, beginning July 31, 2023, and will pay royalties to AbbVie for licensing its Humira patents once the biosimilar product is launched. AbbVie will not make any payments to Mylan under the terms of the agreement.
Humira is approved by the FDA for 10 indications, including the treatment of noninfectious intermediate and posterior uveitis and panuveitis.
“AbbVie’s Humira patents reflect the groundbreaking work of AbbVie scientists in the field of fully human biologics and our investment in patient-focused innovation,” Laura Schumacher, executive vice president of external affairs, general counsel and corporate secretary for AbbVie, said in the release. “We understand the importance of balancing innovation and accessibility, and our agreement with Mylan for its Humira biosimilar maintains that balance.”
AbbVie previously entered global resolutions with Amgen and Samsung Bioepis regarding their biosimilar adalimumab products. Mylan’s license date will not be accelerated by the other companies’ market entries.