Boehringer Ingelheim finally signs licensing deal for Humira biosimilar

Home/Pharma News | Posted 21/06/2019 post-comment0 Post your comment

Boehringer Ingelheim (Boehringer) has finally given in and signed a licensing deal for its Humira biosimilar, Cyltezo (adalimumab), in the US.

24-AA011041

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2019 Pro Pharma Communications International. All Rights Reserved.

Source: AbbVie

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010