Friday, July 25, 2014

Here we go again: biologicals are chemicals, too

I should probably quit beating this drum, but I cannot resist this one. From the Washington Post's Health Reform Watch, Jason Millman writes about the new FDA biosimilars news:
The Food and Drug and Administration for the first time has accepted an application for a copycat version of what's known as a biologic, which is a complex drug made from proteins of living organisms. These biologics are cutting-edge therapies that can be more effective than regular drugs made from chemicals — and, not surprisingly, they also can be expensive.
What's the right way to talk about this? Do you go back to "everything is chemicals", or do you say "small molecules"? I dunno.  


  1. The distinction being made is more about the how being manufactured than the what products are. I agree statement is not very clear about a focus on synthetic routes to make traditional small molecule drugs verses a biosynthetic derived drugs although the article does say made form proteins of living organisms then later includes again mention that biologics come from living things. Although I am doubtful general public audience would appreciate or care there are many practical and practicing differences in these two approaches, particularly related to process and analytical issues that generally make the concept of biosimilar more complex than a small molecule generic but even if just comparing on molecular basis there are few small molecule that contain the level of structural complexity in most biologics.

    I am actually more concerned with biologics being described as cutting edge therapies with implication that regular drugs are not so classified because would argue that the majority of novel small molecule drugs still involve exploitations of new info or areas where remains not yet routine even when termed as a traditional approach.

  2. The drugs are made from chemicals - they're not chemicals themselves. So long as they're good drugs, that is - heroin, of course, is still a chemical. I mean, it's acetylated - that sounds really technical and chemically. Nobody in their right mind would use a chemical to treat themselves.

  3. It brings to mind what my grandmother used to say about if it looks like a duck and walks like a duck..I think we all know the rest.

  4. @Chemist NC,

    That's either really great sarcasm or Food Babe is using your screen name.

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