Feature Pharmaceuticals

Monoclonal antibodies: magic bullets with a hefty price tag

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e8346 (Published 12 December 2012) Cite this as: BMJ 2012;345:e8346
  1. Allen F Shaughnessy, professor
  1. 1Tufts University School of Medicine, Boston, Massachusetts, USA
  1. Allen.Shaughnessy{at}Tufts.edu

Sales of monoclonal antibodies are projected to reach more than $160bn in the US alone over the next few years so is it any wonder that drug companies fiercely protect their profits? Allen Shaughnessy considers why these unique and complex drugs are so eyewateringly expensive

The pharmaceutical industry just doesn’t feel the love these days. Mistrust abounds among the general public as well as within the medical industry. It’s no surprise, then, that eyebrows raise and fingers point when a company withdraws an effective drug from the market shortly after proof is published of its benefit in a completely new treatment arena. What is it up to?

Alemtuzumab is a monoclonal antibody marketed to treat chronic lymphocytic leukaemia. It has also been used, off-label, for multiple sclerosis, and last month two phase III studies were published showing its efficacy and superiority over interferon beta-1a.1 The US Food and Drug Administration and the European Medicines Agency are considering approval for this indication.

By now many patients with multiple sclerosis should be taking the drug, even though it hasn’t yet been sanctioned for this use by regulatory agencies. But Genzyme, a Sanofi company, withdrew it from the market two months before these studies were published. Some predict that once it is approved for multiple sclerosis alemtuzumab will be re-released under a new brand name (and at a much lower dose than that used for leukaemia), this time at a much higher cost.2

From a business perspective, this move makes sense. The cost of Campath, the brand name for the leukaemia version, was about $60 000 (£37 000; $46 000) a year. Lowering the dose to that used to treat multiple sclerosis would have reduced the price to $6000 a year.

This would have been a bargain basement price for immunomodulator treatment of multiple …

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