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The Mercury News had a good article recently on patients hopes for lower costs of biologics drugs such as human growth hormone and other such drugs.

New drug approval raises hope for cheaper medicine

I think the hope may be premature and that there is most likely not going to be a flood of biogenerics. The FDA has made it clear that they don’t consider the approval of Omnitrope ® (somatropin) to be a biogeneric and actually use the phrase “follow on protein product”. I don’t think the American public is going to see biogenerics anytime soon and I predict it will take action in Congress to get this moving forward. I do believe the issue of how you get a biogeneric on the market needs to be addressed; what is the process and what testing or clinical trials need to be done to protect the public but also keeping in mind that the high cost of biologics means some patients will not get treatment. It is always a balancing act; protecting the public vs the impact of people not being able to afford their medicines. The US decided back when the generics drug business was given a process by which to get cheaper medications on the market, that was the way we wanted to control prices; by allowing and facilitating competition. I think we need a process for biogenerics and it should have been started several years ago.

However, I feel the FDA needs to get back on track and improve it’s reputation first and foremost. But this shouldn’t be used as a excuse for not attempting to make progress on biogenerics. However, working on a process for biogenerics before working on its reputation is a path to failure in my opinion.

Technorati Tags: biogenerics, FDA, somatropin

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