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by michael_j_ward 2336 days ago
Gracias for the information. I had to look up biologic medicine to understand what the difference is with other drugs like say acetaminophen. This article from forbes laid it out [1].

TLDR:

1) Biologic / large molecule drugs (insulin) are much harder to produce than small molecule drugs like acetaminophen.

2) The FDA thus requires a lengthly, costly approval process to make generic large-molecule drugs. And since often these drugs are not atom-by-atom the same like small molecule drugs, they are referred to as "bio-similar"

3) Additionally- though least clear from the article, while the patent on a large molecule drug does expire after 20 years in the same way as small-molecule drugs, it appears that the larger-molecule gives a wider area to patents that can be applied to it. The article hints at, but does not make explicit, a mechanism for "evergreening" as I tried to clarify elsewhere in these comments.

Anyways, thought I'd write it up the TLDR because this background info would have been useful to know prior to engaging in this comment section.

Gracias again

[1] https://www.forbes.com/sites/theapothecary/2019/03/08/biolog...