Just what we need, cheaper EPO.

September 19, 2007

Nature has an editorial on an upcoming surge in cheap EPO due to a European Commission approval of “generic” EPO to compete with Amgen’s product (Epogen) and the one J&J licenses from Amgen (Aranesp).

Now that the commission has allowed other companies to market their own version, revenues from Johnson & Johnson’s estimated 250,000 European customers look set to erode. Sandoz, the generic-drugs branch of Novartis, said on 10 September that it will have its version of the drug on the market in the United Kingdom and Germany as soon as October, and that it will cost 25–30% less than Johnson & Johnson is charging.

Great. Coming to local amateur bike clubs all over Europe…healthy young men dying in their sleep.

Not so fast in the US:

But at the moment the United States does not have an abbreviated regulatory system for biosimilars, which seek simply to mimic the drugs already on sale, so — with rare exceptions — there is no way into that market.

But Congress wants a fast-track:

This year Congress vowed to put this matter right. A bill …would give biotech companies twelve years of market exclusivity on any new biological drug from the time that it is approved. This is longer than they might get from patent protection alone, which starts to run out as soon as the patent is granted even if the drug has not been approved. Companies with an interest in making biosimilars would, for their part, receive an abbreviated pathway to FDA approval of their follow-on products once that twelve-year period is up.

But neither the generics industry nor the biotech industry seem to be pushing to have this compromise passed by the House.

Why? Well the biotech industry may not think that the minor up-front extension pays against the odds that the generic industry will fail to compete. And as far as the generics go?

The generics industry is assuming that it will get a better deal in 2009, under a new US president.

Stop bike doping, vote Republican! …or is that a little too narrow of “issues voting”?

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