Boehringer Ingelheim (Boehringer) has finally given in and signed a licensing deal for its Humira biosimilar, Cyltezo (adalimumab), in the US.
Boehringer had been the only company to resist making a deal with AbbVie despite being sued by the company, which had claimed that Boehringer’s biosimilar was stepping on dozens of its Humira patents. Boehringer in its defence claimed that AbbVie was using a ‘patent thicket’ of overlapping and add-on patents, as well as the litigation process itself, as a mechanism to protect its blockbuster [1].
AbbVie announced on 14 May 2019 that it had resolved US Humira patent litigation with Boehringer. Under the terms of the agreement, AbbVie will grant Boehringer a non-exclusive licence to AbbVie’s intellectual property relating to Humira in the US.
The licence will allow Boehringer’s adalimumab biosimilar, Cyltezo, to be launched in the US on 1 July 2023. In return, Boehringer will pay royalties to AbbVie for licensing its Humira patents once its biosimilar is launched. This does not affect Boehringer’s adalimumab biosimilar in Europe, which was approved back in November 2018 [2].
This latest deal with Boehringer brings the number of deals made by AbbVie for adalimumab biosimilars up to nine, see Table 1.
| Table 1: Overview of adalimumab biosimilar deals in the US
|
| Company
|
Biosimilar / approval date
|
AbbVie deal entry date
|
| Amgen
|
Amjevita / 23 Sep 2016
|
31 Jan 2023 [3]
|
| Samsung Bioepis
|
Not yet approved
|
30 Jun 2023 [4]
|
| Boehringer Ingelheim
|
Cyltezo / 25 Aug 2017
|
1 Jul 2023
|
| Mylan
|
Not yet approved
|
31 Jul 2023 [5]
|
| Fresenius Kabi
|
Not yet approved
|
30 Sep 2023 [1]
|
| Sandoz (Novartis)
|
Hyrimoz / 30 Oct 2018
|
30 Sep 2023 [1]
|
| Momenta
|
Not yet approved
|
20 Nov 2023 [1]
|
| Pfizer
|
Not yet approved
|
20 Nov 2023 [1]
|
| Coherus
|
Not yet approved
|
15 Dec 2023 [6]
|
Patients For Affordable Drugs (P4AD), has called these agreements pay-for-delay deals and has asked the Federal Trade Commission (FTC) to investigate whether AbbVie’s deals are anticompetitive and violate antitrust laws [4]. The patient group also points to bragging by AbbVie’s Chief Financial Officer Bill Chase, who reportedly told investors ‘you’ve seen us execute very nicely with our legal strategy and the settlements around the US events to delay the onset of [loss of Humira’s exclusivity] into the 2022–2023 time period’.
In Europe, Humira’s composition of matter patent expired in October 2018, opening the door to eight biosimilars already approved by the European Commission. These include Amgen’s Amgevita and Solymbic, Boehringer Ingelheim’s Cyltezo, Sandoz’s Halimatoz, Hefiya and Hyrimoz, Mylan’s Hulio and Imraldi from Samsung Bioepis [7].
Related article
Boehringer wins access to Humira documents as Janssen’s Remicade is relisted in Quebec
References
1. GaBI Online - Generics and Biosimilars Initiative. AbbVie makes more deals delaying adalimumab biosimilars in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 21]. Available from: www.gabionline.net/Pharma-News/AbbVie-makes-more-deals-delaying-adalimumab-biosimilars-in-the-US
2. GaBI Online - Generics and Biosimilars Initiative. EC approval for adalimumab biosimilar Cyltezo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 21]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-adalimumab-biosimilar-Cyltezo
3. 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 2019 Jun 21]. Available from: www.gabionline.net/Biosimilars/News/Amgen-s-adalimumab-biosimilar-will-only-be-launched-in-US-in-2023
4. 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 2019 Jun 21]. Available from: www.gabionline.net/Biosimilars/General/AbbVie-and-Samsung-Bioepis-reach-patent-deal-over-Humira-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. AbbVie signs another licensing deal for adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 21]. Available from: www.gabionline.net/Pharma-News/AbbVie-signs-another-licensing-deal-for-adalimumab-biosimilar
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 21]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
7. GaBI Online - Generics and Biosimilars Initiative. AbbVie and Coherus sign licensing deal for Humira biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 21]. Available from: www.gabionline.net/Pharma-News/AbbVie-and-Coherus-sign-licensing-deal-for-Humira-biosimilar
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