QDIS Blog

A recent article on the biogenerics market from a money perspective has appeared on the CNN Money site.

Biogenerics face FDA issues amid biotech barriers. - Aug. 15, 2006:

They predict that the biogeneric market will be $20 billion by 2010, only 4 years away. The question is, how much of that market will the US have vs Europe and the rest of the world.

I personally think there are two areas of concern. One is the process by which biogenerics will be approved in the US. It appears to me that the FDA really isn’t going to do anything about it unless forced by congress. My feeling is they will continue to slowly approve product just as they did with Omnitrope. So instead of having a streamlined well laid out process, the standard full testing of products seems to be the expectation.

Many companies are not waiting to see what the US FDA may decide. As an example, Teva, a large generic manufacturer in Israel has recently purchased biological manufacturers in Mexico and Lithuania. Another example is Barr Labs which is attempting to buy Pliva biologics manufacturers in Croatia. This is too bad, because it means the US may miss out on the job creation that could come from having these operations within the US.

Second without biogeneric or “follow on protein products”, healthcare costs will continue to increase at a rapid rate. Since these biological drugs treat serious indication and they are so costly, they can have a large affect. As more and more big pharmaceutical companies, whose blockbuster drugs are expiring turn to biological drugs, the situation will only get worse.

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