AbbVie announced on 17 July 2018 patent license agreements with Mylan over its proposed biosimilar adalimumab product. Under the terms of the agreements, AbbVie will grant Mylan a non-exclusive licence on specified dates to AbbVie’s intellectual property relating to Humira in the US and in various other countries around the world in which AbbVie has intellectual property, excluding Europe.

The licence will allow Mylan’s adalimumab biosimilar to be launched in the US on 31 July 2023. This date, says AbbVie, will not be accelerated by biosimilar entries by Amgen or Samsung Bioepis. In addition, Mylan will pay royalties to AbbVie for licensing its Humira patents once its biosimilar is launched.

AbbVie made a deal with Amgen in October 2017 regarding Amgen’s adalimumab biosimilar Amjevita (adalimumab-atto)/Amgevita (ABP 501), allowing biosimilar entry in the US on 31 January 2023 [1]. Then in April 2018 the company also announced a ‘global resolution’ with biosimilars maker Samsung Bioepis ending all patent litigation regarding Humira and allowing entry of a biosimilar on 30 June 2023 [2].

These deals have been criticized by patient groups for delaying the entry of biosimilars. However, AbbVie has stated that the settlements are in no way pay-for-delay arrangements. The company has said that it is not paying the biosimilar companies and has pointed out that in fact they will be paying royalties to AbbVie once their adalimumab biosimilars launch in the US.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Amgen’s adalimumab biosimilar will only be launched in US in 2023 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Aug 31]. Available from: www.gabionline.net/Biosimilars/News/Amgen-s-adalimumab-biosimilar-will-only-be-launched-in-US-in-2023
2. GaBI Online - Generics and Biosimilars Initiative. AbbVie and Samsung Bioepis reach patent deal over Humira biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Aug 31]. Available from: www.gabionline.net/Biosimilars/General/AbbVie-and-Samsung-Bioepis-reach-patent-deal-over-Humira-biosimilar

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