Sunday, July 30, 2006

Biosimilar But Not Quite

If it impossible to characterize exactly how a drug does what it does why is a copy any different from the real thing since copy reproduces the behavior of the real thing faithfully.

..while it might be feasible to say what a new drug does, after extensively testing it in clinical trials, it's not possible to say exactly what it is. And if you can't describe the exact structure and essential nature of the original, then, naturally, you can't say that something else is an exact copy of it.

To a lay person this describes the efficacy of herbal remedies that have been around forever but cannot be characterized or synthetically replicated by "current analytical methods". Not surprising that these hard to define biopharmaceuticals the article describes are "complex proteins derived from living organisms, cultured from cells in a laboratory". I would rather go with the Golden Seal than a half-baked attempted at playing God in some high-tech lab.

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