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3 December 2018Americas

AbbVie and Pfizer in Humira licensing deal

AbbVie has granted Pfizer a non-exclusive global licence to its Humira (adalimumab) IP, as announced on Friday, November 30.

Humira is used to treat a number of illnesses, including arthritis, Crohn’s disease, chronic psoriasis and juvenile idiopathic arthritis.

Under the terms of the agreement, Pfizer will pay AbbVie royalties for licensing its Humira patents.

Pfizer also acknowledges the validity of the licensed patents as part of the deal and all pending litigation relating to Pfizer’s proposed adalimumab biosimilar will be withdrawn.

Further terms of the agreement are confidential.

Richard Blackburn, global president of inflammation and immunology at Pfizer, said: “This settlement will facilitate patient access to Pfizer’s proposed adalimumab biosimilar which we expect to be an important addition to our broad portfolio of biosimilar medicines.”

In the EU, Pfizer can launch its adalimumab biosimilar as soon as it has approval from the European Medicines Agency (EMA).

However, in the US, Pfizer’s licence will not begin until November 20, 2023.

Last month, biotech company Momenta obtained the rights to use AbbVie’s Humira IP, enabling the global commercialisation of Momenta’s proposed Humira biosimilar, M923.

Momenta’s US licence is due to commence on November 20, 2023, although it can launch in the EU as soon as the EMA has approved M923.

AbbVie has also granted patent licences to  Amgen (beginning January 31, 2023),  Samsung Bioepis (June 30, 2023),  Mylan (July 31, 2023), Sandoz (September 30, 2023), and Fresenius Kabi (September 30, 2023).

Fresenius Kabi has already submitted a marketing authorisation application for its adalimumab biosimilar candidate at the EMA.

Meanwhile, the National Health Service England last week announced that it expects to save around £300 million ($383 million) on adalimumab costs after negotiating deals with five generic manufacturers in addition to AbbVie, the manufacturer of the originator medicine.

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More on this story

Americas
15 May 2019   Boehringer Ingelheim has become the latest biosimilar maker to resolve litigation over AbbVie’s arthritis treatment Humira.
Big Pharma
20 April 2021   Pfizer has settled lawsuits against two Indian generics makers who had informed the US Food and Drug Administration of plans to launch their own version of Xeljanz XR.
Biotechnology
6 January 2022   Biotech Allele has dropped its lawsuit accusing Pfizer and BioNTech of infringing technology covering a fluorescent protein used in COVID-19 vaccines.

More on this story

Americas
15 May 2019   Boehringer Ingelheim has become the latest biosimilar maker to resolve litigation over AbbVie’s arthritis treatment Humira.
Big Pharma
20 April 2021   Pfizer has settled lawsuits against two Indian generics makers who had informed the US Food and Drug Administration of plans to launch their own version of Xeljanz XR.
Biotechnology
6 January 2022   Biotech Allele has dropped its lawsuit accusing Pfizer and BioNTech of infringing technology covering a fluorescent protein used in COVID-19 vaccines.