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Biosimilar substitution: Listen to all lobbyists Posted 30/07/2009

In December 2007 a British parliamentary review was conducted on the issue of biosimilars. At a British meeting it was told that “automatic substitution rules do not apply to biologicals.” The recommendation of the panel was that “there should be an urgent ban on the substitution of biopharmaceuticals in the UK until effective safeguards can be relied upon.”

As reported by Health Editor of The Times Nigel Hawkes in the British Medical Journal, this parliamentary review had been funded by a grant from the leading biotechnology company Amgen. Evidence was taken from seven witnesses, at least two of them with a connection to Amgen: the company’s regulatory affairs director and a US lawyer paid as a lobbyist for Amgen.

According to biosimilars manufacturers, these drugs are the biological equivalent of generic drugs: cheaper, ‘me-too’ products that are brought on the market once the original patents expire. Given the high prices of modern biological drugs such as the monoclonal antibodies, the sooner that biosimilars are with us, the better it is for the national healthcare system and its patients.

However, the issue is a tricky one: there remain uncertainties about how straightforward it will be to substitute biosimilars and how much money it will save.

Biological drugs are not identical in the same way that generic chemical ones are, and switching from a branded product to a biosimilar could cause unexpected side effects.

The EMEA has laid down rules for licensing biosimilars that are much tougher than those for generic drugs. Companies that make biosimilars will have to carry out clinical trials, albeit on a smaller scale than the trials of the originator product, to show that their clinical effects are equivalent. Their manufacturing quality will also be stringently tested.

But rules on substitution are a national matter. Several countries, including France and Spain, have passed laws that prevent automatic substitution. It would suit Amgen if others followed their lead. Clearly, Amgen’s interest is that substitution should be made as difficult as possible. Then its powerful position as the originator of products such as Enbrel and Epogen will be sustained for much longer.

However, the greater the obstacles to substitution, the lower the likely savings to the national healthcare system. Amgen maintains that the savings from substitution are likely to be modest, of the order of 10-20%. But according to a report published on 11 February 2008 by Mr Robert Shapiro (commissioned by Insmed, a biosimilars manufacturer), biosimilars could safe the US$378 billion (Euros 271.85 billion) over the next 20 years.

So the message entirely depends on who is doing the talking. Companies have interests that shape their views. Parliaments should listen to all of them, or they risk serving only the interests of those who lobby hardest.

Source: BMJ 2008;336:588.

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