In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|July 18, 2018
AbbVie Signs Patent License with Mylan for Humira Biosimilar
Author(s)BioPharm International Editors
AbbVie will grant Mylan license to launch a biosimilar to AbbVie’s Humira.
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On July 17, 2018, AbbVie announced that it signed patent license agreements with Mylan over Mylan’s proposed biosimilar to AbbVie’s Humira (adalimumab). AbbVie’s product made $18.43 billion in
Under the terms of the agreements, AbbVie will grant Mylan a non-exclusive license on specified dates to AbbVie's intellectual property relating to Humira in the United States and in various other countries around the world in which AbbVie has intellectual property, excluding Europe.
According to AbbVie, Mylan's US license will begin on July 31, 2023 and will not be accelerated by the entries of Amgen's or Samsung Bioepis' Humira biosimilar products. Mylan will pay royalties to AbbVie for licensing its Humira patents once Mylan’s biosimilar product is launched. Mylan acknowledges the validity of the licensed patents. AbbVie will make no payments to Mylan.
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