The settlement means that Amgen’s adalimumab biosimilar will be launched in the European Union on 16 October 2018, but will only be launched in the US on 31 January 2023.

Amgen’s adalimumab biosimilar Amjevita (adalimumab-atto)/Amgevita (ABP 501) was approved by the US Food and Drug Administration (FDA) in September 2016 [1] and by the European Medicines Agency (EMA) in January 2017 [2].

The reason for the delay to 2023 in the US is largely due to a whole host of patents on Humira. While the composition of matter patent covering Humira expired in December 2016, AbbVie has stated that non-composition of matter patents covering Humira expire no earlier than 2022.

The decision will mean that Humira will enjoy more than 20 years exclusivity on the US market. It was approved by FDA in December 2002 [4]. This is expected to be costly for the US, considering the fact that the drug had worldwide sales of US$16.1 billion in 2016 alone. In fact, the deal is estimated to cost the US Centers for Medicare and Medicaid Services at least US$1.48 billion (considering a price reduction of just 15% with just one biosimilar on the market). FDA also approved another adalimumab biosimilar in August 2017, Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) [3].

Competition for Humira in the European Union (EU) is expected to reduce prices with multiple adalimumab biosimilars to hit the EU market in the near future. In fact, the EU could have at least five adalimumab biosimilars before the US has a single one on the market. Amgen, Boehringer Ingelheim and Samsung Bioepis have all already received EMA approval for adalimumab biosimilars [5]. Fujifilm Kyowa Kirin Biologics and Sandoz submitted applications for their adalimumab biosimilars to the agency in May and June 2017, respectively [6, 7].

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approval for Amgen’s adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 20]. Available from: www.gabionline.net/Biosimilars/News/FDA-approval-for-Amgen-s-adalimumab-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. EMA approval for adalimumab biosimilars Amgevita and Solymbic [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 20]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-adalimumab-biosimilars-Amgevita-and-Solymbic
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab biosimilar Cyltezo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 20]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-adalimumab-biosimilar-Cyltezo
4. Derbyshire M. Patent expiry dates for biologicals: 2016 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(1):27-30. doi:10.5639/gabij.2017.0601.006
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 20]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
6. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for adalimumab biosimilar from Fujifilm Kyowa Kirin Biologics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 20]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-adalimumab-biosimilar-from-Fujifilm-Kyowa-Kirin-Biologics
7. GaBI Online - Generics and Biosimilars Initiative. Adalimumab and rituximab biosimilars from Sandoz accepted for review by EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 20]. Available from: www.gabionline.net/Biosimilars/News/Adalimumab-and-infliximab-biosimilars-from-Sandoz-accepted-for-review-by-EMA

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