UK investigation suggests Merck broke competition law

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UK investigation suggests Merck broke competition law

Biosimilares/General | Posted 23/06/2017 0 Post your comment

A provisional statement from the UK Competitions and Markets Authority (CMA) says that Merck Sharp & Dohme (MSD) ran an anticompetitive discount scheme for anti-inflammatory drug Remicade (infliximab).

Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It is used to treat autoimmune diseases, such as ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.

Patents on Remicade expired in Europe in February 2015 [1], and recent years have seen an increasing number of biosimilar versions launch on the market. Samsung Bioepis, for example, recently received approval for an infliximab biosimilar (Flixabi) in the European Union [2].

In an attempt to defend itself from cheaper biosimilar versions, MSD launched a discount scheme for Remicade. The company cut prices in the UK by around a quarter through rebates and discounts to the UK’s National Health Service (NHS). The CMA opened an investigation into this practice back in December 2015.

In a statement of objections issued on 23 May 2017, the CMA says MSD broke competition law by abusing its dominant position in the market. However, the findings are only provisional. The CMA says they will consider representations by the company before formally concluding a breach of competition law.

MSD said it is cooperating fully with the investigation and that they are ‘confident’ the findings will show they have complied with competition law. They say the discounts meant infliximab was ‘competitively priced’ and provided savings to the NHS without harming competition.

This follows a series of similar statements from the CMA, which has been investigating several pharmaceutical companies recently. In April 2017, they alleged that Actavis and Concordia entered into illegal agreements that enabled them to charge higher prices for hydrocortisone [3] and in January 2017 fined Pfizer and Flynn Pharma almost GBP 90 million for increasing the prices of phenytoin anti-epilepsy tablets [4].

Biosimilars of infliximab

References
1. 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
2. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of infliximab biosimilar Flixabi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 23]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-infliximab-biosimilar-Flixabi
3. GaBI Online - Generics and Biosimilars Initiative. UK authority accuses Actavis UK and Concordia of illegal agreement. [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 23]. Available from: www.gabionline.net/Policies-Legislation/UK-authority-accuses-Actavis-UK-and-Concordia-of-illegal-agreement
4. GaBI Online - Generics and Biosimilars Initiative. UK fines Pfizer and Flynn following epilepsy drug price hikes. [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 23]. Available from: www.gabionline.net/Policies-Legislation/UK-fines-Pfizer-and-Flynn-following-epilepsy-drug-price-hikes

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Source: MSD, UK Government