Pharmaceutically Speaking: USPTO vs FDA?

Danie Roy

Those of you familiar with the Pharmaceutically Speaking series know I’ve written a bit on generics, biologics, and biosimilars before. I’ve also touched a bit on how Patent does not equal FDA approval (and vice versa). Crash course version:

Generics are versions of drugs that have gone off-patent. That is, the patent protection has run out on them, and the active ingredients in the drugs are now free to use. Different inactive ingredients must be used, and your generic must be approved by the FDA to be within a comparable effectiveness range of the original. Biologics are pretty close to what they sound like: medicine produced biologically rather than chemically. Biosimilars are the generics of biologics.

Of course, biosimilars are a little more complex than that, for the same reason organisms are more complex than chemicals. For some more in-depth reading, the links above have a good bit of information buried in them. Right now, I’m going to explain why the US biosimilar approval process seems to be putting standards from the USPTO and FDA at odds.

See, with what we think of as generics, the chemically-based drugs, they’re pretty much interchangeable. Some people may react differently to inactive ingredients, but such cases are few and far between. Very little research is required to prove that Drug X will do the same thing as Drug Y because they both have Chemical Z. Drug X might just have Filler A while Drug Y might have Filler B. With biologics, the process is a little harder to prove.

As I’ve said before, biologics, by nature, are more complex than traditional drugs. They come from individual cell or protein lines, and the tiniest difference, even an imperceptible one, could be the difference between life and death. In order for a biologic to have an interchangeable biosimilar, significantly more testing has to be done to prove that switching back and forth between the drugs will have no effect. Add to this that biologics need time to build up in your system to truly work as intended, and the research gets expensive fast. Plus, the interchangeable guidelines as set by the FDA require sharing how all the biosimilars were made to the makers of the original biologics… which is bound to cause IP disputes. And, without the interchangeable label, you still need a separate prescription for the biosimilar.

Assuming that the kinks all get worked out and we do get interchangeable biosimilars, it could be a very long time before we see those drugs. And even then, we won’t be getting as a big a discount as hoped for… somewhere in the 10-20% range. Remember, keep your fingers crossed, but don’t hold your breath.