Industry leaders dismiss bio generic threat

Cheap generic equivalents to biotech drugs are still “years” away from being commercially viable, industry leaders have said. Generic biotech drugs could eventually come to threaten biotech company profits much as copycat versions of small molecule drugs have hurt mainstream pharmaceutical producers.

But president and CEO of the US Biotechnology Industry Organisation Jim Greenwood played down the fears, telling Reuters that the international legal and regulatory framework for “bio-generics” was in its infancy. “I think we are probably several years away,” he said.

“It is quite a different thing to try to produce a bio similar — even tiny variations in structure can stimulate immune responses in patients.” Incoming chairman of the UK’s BioIndustry Association Simon Best agreed, saying that although the EU held a lead over the US, it would not be an issue for some time. “You might see something on the market in Europe a bit quicker, but my hunch is that would be still be two to three years away,” he said.

Nonetheless, the European Medicines Agency has already issued guidelines on key products, with the FDA considering the issue later this month. Analysts say that several problems will have to be overcome before generic companies are able to prove that their versions of complex biological drugs are equivalent to the originals, and that they will probably have to face a further level of clinical trials.

Generic firms, who had hoped that the first expired patents would have been producing income for them by now, have expressed frustration at the slow growth of the market. In an attempt to push the market forward, Sandoz, the generic arm of Novartis, sued the FDA in September for delaying Omnitrope, its generic version of human growth hormone which has already been approved elsewhere. The case has become test for bio-generics and will dictate progress made elsewhere.

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