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FDA Unveils Biosimilars Guidance 30

Posted by timothy
from the well-it's-kind-of-like-kale dept.
ananyo writes "The U.S. Food and Drug Administration has released its long-anticipated draft guidance for drug makers interested in making generic forms of biological drugs such as enzymes and antibodies. The move could open the door for cheaper versions of some of medicine's most expensive drugs, but it is still unclear how many companies will be willing to tackle the challenges and uncertainties of making 'biosimilar' drugs. Copying biological molecules is a stickier proposition than making ordinary generic medicines because proteins are typically much larger and more complex than small molecule drugs. They are also often produced in cell cultures, and even small variations in how the cells are grown can change the properties of the protein produced."
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FDA Unveils Biosimilars Guidance

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  • Seems to me... (Score:2, Interesting)

    by jamstar7 (694492) on Friday February 10, 2012 @11:35PM (#39002751)
    If you want biological molecules for drugs, the last thing you want to do is try to synthesise them Why not just open up yeast to genetic engineering and have the modified yeast create your molecules by the ton? Once you have the research and modifications done, you can grow those yeasts for pennies.

Computers will not be perfected until they can compute how much more than the estimate the job will cost.

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