AbbVie announced Tuesday that it signed patent license agreements with Mylan over the latter's proposed biosimilar referencing Humira (adalimumab). Under the agreed terms, AbbVie said it will grant Mylan a non-exclusive license for Humira in the US and in various other countries around the world in which AbbVie has intellectual property, with the exception of Europe.
AbbVie general counsel Laura Schumacher remarked "we understand the importance of balancing innovation and accessibility, and our agreement with Mylan for its Humira biosimilar maintains that balance." Under the agreed terms, Mylan will pay royalties to AbbVie following the launch of its biosimilar version of Humira.
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Specifically, AbbVie said Mylan's US license will begin on July 31, 2023, and "will not be accelerated" by either Amgen's or Samsung Bioepis'respective entries. Last year, AbbVie signed a deal permitting Amgen to launch its Humira biosimilar Amjevita in the US on January 31, 2023. The FDA approved Amjevita in 2016, while European regulators cleared the biosimilar last year.
In April, AbbVie reached a similar accord, under which Samsung Bioepis will be allowed to introduce its Humira biosimilar Imraldi, if approved, in the US as of June 30, 2023. Imraldi, also known as SB5, was cleared by the European Commission in August last year.
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