The settlement means that the adalimumab biosimilar produced by Samsung Bioepis will be launched in the European Union on 16 October 2018, but will only be launched in the US on 30 June 2023.

South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture, Samsung Bioepis received approval from the European Medicines Agency for its adalimumab biosimilar Imraldi (SB5) in June 2016 [1], but has not yet received regulatory approval in the US. In Europe, Imraldi will be commercialized by Biogen.

The decision mimics another deal made by AbbVie with Amgen in October 2017 regarding Amgen’s adalimumab biosimilar Amjevita (adalimumab-atto)/Amgevita (ABP 501) [2] and will mean that Humira will enjoy more than 20 years exclusivity on the US market. It has been estimated that this could cost the US Centers for Medicare and Medicaid Services at least US$1.48 billion [3].

Patient group, Patients For Affordable Drugs (P4AD), has called these agreements pay-for-delay deals. In a letter to Congress and the Federal Trade Commission (FTC), the patient group asked the FTC to investigate whether AbbVie’s recent deal with Samsung Bioepis is anticompetitive and violates antitrust laws.

David Mitchell, President and Co-founder of P4AD said that ‘AbbVie is using pay-for-delay deals to keep a cheaper [biosimilar] off the market and patients are the victims’. He added that P4AD believes ‘it is illegal and anti-competitive’ and that they are ‘asking the FTC to step in and protect patients from AbbVie’s price hikes’. The group says that ‘the price of Humira has more than doubled in the last five years’, pointing to the company’s latest price increase of 9.7% in January 2018.

P4AD also reached out to its nationwide network of patients to encourage them to write to their senators in support of changes that would end similar pay-for-delay tactics. As of 19 April 2018, more than 1,200 patients had written to show their support.

AbbVie, however, has strongly objected to the use of the term ‘pay-for-delay’ to describe its adalimumab agreements. The company has stated that AbbVie’s settlements with Amgen and Samsung Bioepis are in no way pay-for-delay arrangements. AbbVie is not paying Amgen or Samsung Bioepis, and in fact both Amgen and Samsung Bioepis will be paying royalties to AbbVie once their adalimumab biosimilar products launch in the US.

References
1.  GaBI Online - Generics and Biosimilars Initiative. EMA approval for adalimumab biosimilar Imraldi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 4]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-adalimumab-biosimilar-Imraldi
2.  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 May 4]. Available from: www.gabionline.net/Biosimilars/News/Amgen-s-adalimumab-biosimilar-will-only-be-launched-in-US-in-2023
3.  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 May 4]. Available from: www.gabionline.net/Biosimilars/News/Humira-deal-could-cost-CMS-US-1.48-billion

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