On 23 May, the CMA issued a statement of objections, which is a provisional finding that Merck Sharp & Dohme Limited (MSD) has breached UK competition law by abusing its dominant position. The CMA's preliminary view is that MSD operated a discount scheme for the supply of Remicade to the NHS that was likely to restrict competition from ‘biosimilar’ versions of infliximab that were new to the market.
Remicade is among the best selling drugs in the world, used to treat chronic diseases such as rheumatoid arthritis and Crohn's disease. The US Food and Drug Administration (FDA) approved it for use in August 1998 and it is sold and marketed in the US by Johnson & Johnson (J&J). In Europe, it received approval in August 1999 and is sold and marketed by MSD.
The European patents on Remicade expired in February 2015 and in the US J&J's patents were ruled invalid in August 2016. Celltrion/Hospira developed a biosimilar (Remsima) which received EU approval in September 2013. Shortly after expiry of the European patents, in December 2015, the CMA opened its investigation into MSD.
More recently, in September 2017, Pfizer Inc - which introduced its own biosimilar (Inflectra), another collaboration with Celltrion in the US in 2016 - launched proceedings in the US District Court for the Eastern District of Pennsylvania, alleging that J&J has "deployed improper exclusionary tactics to maintain the dominance of its flagship product". Pfizer's complaint states that the core features of J&J's "Biosimilar Readiness Plan" involved "exclusionary contracts that foreclose Pfizer's access to an overwhelming share of consumers, coupled with anticompetitive bundling and coercive rebate policies designed to block both insurers from reimbursing, and hospitals and clinics from purchasing, Inflectra or other biosimilar Remicade despite their lower pricing".
Due to the nature and regulatory approval of biosimilars, in most countries it is not usually possible for patients to switch between the originator biologic and the biosimilar version (a notable exception is the recent large scale Nor-Switch study where the Norwegian health authority switched 500 patients from Remicade to Remsima). This means that a successful biosimilar launch will often depend on being able to access patients who are either newly diagnosed or where their treatment regime is being changed; rather than patients who are already being maintained on the originator version.
As a result, where the originator biologic is offering rebates or requires payers to enter into exclusive contracts, there is the potential for foreclosure to take place if it leads to exclusion of a rival. Whether the foreclosure is anti-competitive or not will depend on a number of issues, including whether:
- the incumbent biologic is dominant in a market;
- competition for the market takes place (this is where there is a competitive process, i.e. a tender, which results in the winner earning the right to supply a given population), and how this is distorted – this may depend on how frequently a tender process takes place and how any exclusivity period overlaps with opportunities to bid for the tenders;
- foreclosure gives rise to consumer harm, for example higher prices;
- there is any evidence of an exclusionary strategy.
In Pfizer's US case against J&J it is alleging that "J&J has induced insurers to enter into contracts that require an explicit commitment not to cover Inflectra at all or to do so only in the rarest of circumstances".
Natasha Pearman is speaking on these and other issues concerning the life cycle management strategies of biologics at this year's European Biosimilars Congress, taking place in London on 24 November.