Editorial note: a slight variation of this appeared last week on The Conversation.
In 2010, the European Ombudsman ruled that the European Medicines Agency should open access to clinical trials data when companies applied to get their drugs on the market. The ombudsman decided public health was more important than considerations of commercial confidentiality.
In February this year, the US pharmaceutical company AbbVie, who make Humira – the best-selling drug in the world today – took legal action against the EMA’s open access policy after they were tipped that competitors had requested access to clinical study reports and the EMA was going to grant it. In one of the most important healthcare legal actions ever taken, the court upheld the pharmaceutical companies’ positions.
On August 27th, EFPIA – The European Federation of Pharmaceutical Industries and Associates - convened a meeting in Bruxelles to look at issues of accessing clinical trial data, at which Neal Parker of AbbVie created quite a fuss, starting off with a wonderful Freudian slip saying that AbbVie’s mission is to discover new diseases.
A video of the meeting is linked to the Trade Wars AbbVie v China post here. Close ot the middle of the meeting, the director general of EFPIA, Richard Bergström, intervened to say
“Most of our members are quite relaxed” about data disclosure. For most products there would be no issues, though for highly competitive fields such as biologics there might be.
“You might get companies from South Korea or China breathing down your neck trying to copy your technology, then you get extra sensitive,”
As noted at the time, this comment raises the question as to whether this is what AbbVie’s action against EMA was really all about? The room and the entire commentariat have been debating access to clinical trial data – but was the action elsewhere?
Enter Inflectra Stage – Left
A little over two weeks after this meeting, EMA provisionally approved Infliximab Biosimilar (Inflectra) for use in Rheumatoid Arthritis, Crohn’s Disease, Psoriasis and related conditions.
Infliximab is the core compound in Remicade. Remicade was developed by Johnson & Johnson. It was one of the first biologics or MABs (monoclonal antibodies), of which AbbVie’s Humira has become the most famous. The branded pharmaceutical industry have always fought hard against generic drugs which eat into their blockbuster profits but they have fought tooth and nail to stop “generic” versions of any biologics being launched.
The argument has been that no generic can be identical to its parent biologic. There are in fact irreducible differences between all original MABs and any derivative biologics. This has given rise to the concept of a Biosimilar. The pipeline for new drugs is so poor that blocking Biosimilars almost seems like a life or death issue for the branded companies.
We must unite against Korea?
Richard Bergström may have let the cat out of the bag mentioning Korea.
Inflimab Biosimilar was made by Celltrion – a Korean company. Celltrion working in collaboration with Hospira, a new kind of pharmaceutical company that has emerged to help develop Biosimilars, based in both the US and UK, filed the application to market Hospira’s Inflectra in America and Europe and Celltrion’s Remsima in other markets.
This could lead to the price of biologics, which can cost anywhere between $20,000 and $500,000 per year falling dramatically, Inflectra - Remsima will likely cost 33% less than Remicade and this will have knock on effects for Humira.
Dr Margaret Chan, Director General of the World Health Organisation, said earlier this year:
“The costs of many new medical products are becoming unsustainable for even the wealthiest countries in the world. [Of the 12 cancer drugs approved last year], 11 were priced above the $100,000 per patient per year. This price is unaffordable, for most patients, most health budgets and most insurance companies. These are problems for all countries, not just the developing world.”
Eastward Look, the Land is Bright?
Up to the MABs, insurance companies like UHG, Humana and others simply paid out on new drugs. They offered a reimbursement rather than an insurance service. But now that biologics are so much more expensive than older drugs, companies in this area, especially larger companies who self-insure like General Motors or WallMart, have to become insurers rather than just reimbursers. And in this arena, a Biosimilar offers insurance companies huge leverage.
Companies like Hospira and Celltrion have a chance to effect huge changes for the better – will they grasp them? Does Salvation lie in the East?
Was AbbVie and EFPIA’s action against EMA a shot across the bows? Was it all about trying to deter EMA from licensing Inflextra – Remsima?