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AbbVie makes more deals delaying adalimumab biosimilars in US Posted 23/11/2018

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Last update: 14 December 2018

US-based pharma giant AbbVie has signed yet more deals with biosimilars makers regarding biosimilar versions of its blockbuster arthritis drug Humira (adalimumab).

AbbVie announced on 11 and 18 October 2018 global resolution of Humira patent disputes with Sandoz and Fresenius Kabi. Then on 6 and 30 November 2018 the company announced patent license agreements with Momenta and Pfizer over their proposed adalimumab biosimilars. Under the terms of the agreements, AbbVie will grant the companies non-exclusive licences 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 Fresenius Kabi and Sandoz’s adalimumab biosimilars to be launched in the US on 30 September 2023 and Momenta and Pfizer’s biosimilars to be launched on 20 November 2023. These dates, says AbbVie, will not be accelerated by biosimilar entries by other companies. In addition, the companies will pay royalties to AbbVie for licensing its Humira patents once their biosimilars are launched. For Pfizer, in the European Union, the company can launch upon approval from the European Medicines Agency.

These latest deals bring the number of deals made by AbbVie for adalimumab biosimilars up to seven. The only company so far resisting a deal with AbbVie is Boehringer Ingelheim (Boehringer), 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 [1]

Samsung Bioepis

Not yet approved

30 Jun 2023 [2]

Mylan

Not yet approved

31 Jul 2023 [3]

Fresenius Kabi

Not yet approved

30 Sep 2023

Sandoz (Novartis)

Hyrimoz / 30 Oct 2018

30 Sep 2023

Momenta

Not yet approved

20 Nov 2023

Pfizer

Not yet approved

20 Nov 2023

Boehringer Ingelheim

Cyltezo / 25 Aug 2017

No deal reached

Boehringer has so far resisted making a deal with AbbVie despite being sued by the company, which claims that Boehringer’s biosimilar steps on dozens of its Humira patents. Boehringer in its defence claims AbbVie is using a ‘patent thicket’ of overlapping and add-on patents, as well as the litigation process itself, as a mechanism to protect its blockbuster.

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 [2]. 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 [4].

Related article
Brand-name drugmakers gain extra days of patent protection

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 Nov 23]. 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 Nov 23]. Available from: www.gabionline.net/Biosimilars/General/AbbVie-and-Samsung-Bioepis-reach-patent-deal-over-Humira-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. AbbVie signs another licensing deal for adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 23]. Available from: www.gabionline.net/Pharma-News/AbbVie-signs-another-licensing-deal-for-adalimumab-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 23]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: Abbvie, Boehringer Ingelheim, P4AD, Momenta

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