Legal and promotional wars being waged against biosimilars

Generics and biosimilars Initiative

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Legal and promotional wars being waged against biosimilars

INICIO/Informes | Posted 16/03/2018 0 Post your comment

Several obstacles contribute to the slow uptake of biosimilars in the US, one of which is the legal and promotional wars being waged against biosimilars by originator companies.

In contrast to the generics market, where originator companies typically stop active promotion of their brand-name products once generics competition enters the market, biologicals manufacturers have indicated that they are willing to fight to protect their blockbuster biologicals.

Take, for example, the case of Humira, the world’s best-selling prescription drug. AbbVie reached a settlement with Amgen, whose biosimilar Amjevita was approved in September 2016 by the US Food and Drug Administration. The settlement means that Amgen’s adalimumab biosimilar will only be launched in the US on 31 January 2023 [1]. This extends the exclusivity period of AbbVie’s blockbuster drug (which brought in US$10.4 billion in US sales in 2016). It has been estimated that this delay could cost the US Centers for Medicare and Medicaid Services (CMS) at least US$1.48 billion [2].

Similar legal disputes have involved other would-be US biosimilars, including Erelzi (etanercept), Ogivri (trastuzumab) and Renflexis (infliximab).

In addition, originators are also investing huge sums in direct-to-consumer (DTC) advertising to build patient loyalty for their biologicals. In 2015 alone, AbbVie spent over US$350 million on Humira’s television, magazine and other DTC advertising.

Editor’s comment
Medicare is a national social insurance programme, administered by the US Federal Government since 1966. It provides health insurance for Americans aged 65 and older who have worked and paid into the system, as well as to younger people with disabilities.

Medicaid is a social healthcare programme in the US for families and individuals with low income and limited resources.

Obstacles to biosimilars uptake in the US

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 Mar 16]. 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. Humira deal could cost CMS US$1.48 billion [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 16]. Available from: www.gabionline.net/Biosimilars/News/Humira-deal-could-cost-CMS-US-1.48-billion

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