FDA Unveils Biosimilars Guidance

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.

I'm sorry, but this is an example of a +4 moderated comment that doesn't know what it's talking about, and does not understand the basic gist of the regulatory issue that this article is dealing with.

Nobody is synthesizing anything, biopharmaceuticals are by definition substances (non-small-molecule) derived from biological organisms, whether engineered or naturally occurring. A bit of explanation: Small molecule drugs (like say, asprin) are chemically simple. As such, it is easy to demonstrate equivalence of a generic to the original; you show all your chemical bonds are in the right place, and that your formulation is rolled up in a pill that gets absorbed the same, those kinds of tests are sufficient for approval.

But biomolecules were treated differently, for the reason that it was impossible to do the same kind of analysis -- an analysis could find all testable parameters exactly the same, but things would work differently simply because it came out of a different manufacturing process. So there were no "generic" biologicals. A second company could copy something like say, Amgen's erythropoetin protein -- but although an identical protein, it would be considered a separate drug, and go through a new approval process just like it was a brand-new drug.

Generic companies have long clamored to allow biologicals to be treated the same as chemical entities,skipping the extremely lengthy and expensive process of doing clinical trials and such again. And of course, the originator companies argued that bio-similars should go through safety trials, too (as they could not be conclusively proved to be identical to the original). So, we had a regulatory tug-of-war running for the past... two decades or so, that has finally been settled (or so it seems at the moment).

As for the various issues of production via various types of organisms is something I don't want to get into right now, but let's just say we're dealing with techniques far more sophsticated than yeast expression these days.

Source: http://rss.slashdot.org/~r/Slashdot/slashdotScience/~3/Rmof0nNG1l8/fda-unveils-biosimilars-guidance

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