Are “me-too” drugs innovative?

Original post at www.pharmainnovationblog.com

By definition, “me-too” drugs are drugs that duplicates the action of an existing drug (1). This type of drugs are always under heavy criticism, due to the lack of improvement over the pioneer drug.

It is stated that me-too drugs does not provide benefits for theconsumer and that it also hinders innovation by decreasing the R&D expenditure that should be spent in other pioneer drugs. I will overlook the economic side of this and focus only in the arguments related to the innovation.

Me-too drugs are a product of sustaining innovation: researchers could develop a new product in a field that was already under heavy patent protection. And that, my friends, is no easy job! (I can clearly picture a board meeting, where board members ask the researches things like “how come you didn’t see this?”).

One point I did not see in my research was the separation of pharmacokinetics and pharmacodynamics, and evaluation of these effects. A different drug having the same pharmacodynamics, but with different pharmacokinetics can make a huge difference in patients with kidneys or liver compromised. This is critical and is often ignored in publications.

I do believe me-too are innovative. The degree of innovation (sustaining or disruptive) is what is open for debate.

(1) A Hollis – WHO report, 2004 (https://www.who.int/intellectualproperty/topics/ip/Me-tooDrugs_Hollis1.pdf)