The ‘global resolution’ ending all patent litigation regarding AbbVie’s Humira, which was agreed between the two companies in September 2017, means that Amgen’s adalimumab biosimilar will be launched in the European Union (EU) on 16 October 2018, but will only be launched in the US on 31 January 2023 [1].

The US$1.48 billion figure has been estimated by RAPS from the 2015 Medicare Part B and Part D spend on Humira (US$1,662,291,827 total) and 2015 Medicaid total spend on Humira (US$805,458,621). If just one competing biosimilar was marketed from 2019 until 2023 (like in the EU) and the total CMS spend on Humira was reduced by 15%, the total spend would be reduced by US$1.48 billion.

This figure also does not take into account the fact that the US Food and Drug Administration (FDA) has actually approved two adalimumab biosimilars and others are expected to be on the way. Although prices for biologicals have not fallen as dramatically when biosimilars enter the market compared to generics entry, price reductions are still expected to be greater when there are multiple entrants.

Amgen’s Amjevita (adalimumab-atto) was approved by FDA in September 2016 [2] and Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) was approved in August 2017 [3].

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Reference
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 2017 Nov 10]. 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. FDA approval for Amgen’s adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 10]. Available from: www.gabionline.net/Biosimilars/News/FDA-approval-for-Amgen-s-adalimumab-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab biosimilar Cyltezo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 10]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-adalimumab-biosimilar-Cyltezo

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