Pegylated interferon: straight to market?

Yesterday it was reported that a team at Imperial College, London have developed a new, cheap version of interferon to treat hepatitis C, by altering its molecular structure. Instead of coating the interferon with sugar, they can insert sugar within the molecule, ensuring a similar therapeutic effect from a different physical structure.

It seems this may get round http://www.gooakley.com/ Roche’s patent for interferon. But the BBC quoted the Association of the British Pharmaceutical Industry as saying that should this prove to be a ‘new’ medicine, trials would need to be undergone before the drug could be marketed.

But I’m not sure that’s right.

Under article 10 of the relevant EC Directive, 2001/83 (download the consolidated version as a PDF file here), toxicological tests and clinical trials do not have to be undertaken for the relevant licensing authority (in the UK, the MHRA) in relation to a drug which is “essentially similar” to one that’s already been on the market for six or ten years (depending on which Member State’s authorities are being asked for a licence). And the MHRA’s guidance makes clear two products are essentially similar if they have the same Occhiali Da sole Ray Ban outlet active ingredient in the same amount; if they have the same pharmceutical form; and if they are bioequivalent – in other words, are taken up by the body at the same rate and in the same way.

It sounds to me from the reports that this new molecular formulation of interferon has almost been designed to meet this test. If Roche have been marketing the existing version somewhere in Europe for six years, it may be possible for Imperial and its partners to piggy back on Roche’s data to get a licence in that member state, then have that licence recognised throughout Europe and market the new product across the EC.

This could be a major test for the existing European legislation on medicines licensing.