Should Pharmaceutical Commercials be allowed on TV?

   / Should Pharmaceutical Commercials be allowed on TV? #71  
Agree on most points.
Potentially dangerous adverse reactions/effects are one of the reasons for the FDA designating a drug as prescription only; although another determination is that benefits must outweigh risks.

A "me-too" drug is another drug in the same class as an existing drug but changed enough to call it a new drug. Good examples here are with the original drug Prilosec(omeprazole), then all the me-toos in the same "proton pump inhibitor class" like Prevacid(lansoprazole), Protonix(pantoprazole), Nexium(esomeprazole), etc. They usually all have very similar efficacy and adverse reactions/effects. Me-toos are different enough that they don't require the patent on the original drug in the class (the "index" drug) to run out.

A "biosimilar" drug refers to another company replicating a large molecule protein brand name drug. Because of the size and complexity of these large molecule protein drugs, it is nearly impossible for a second company to reproduce the original company's process and produce exactly an identical large molecule drug. However, they can very closely reproduce it to have the same function and they are required to show the FDA that it is equivalent to the original drug. The concept is very similar to a "generic" drug which refers to small molecule drugs which can be chemically reproduced exactly and both generics and biosimilars require patent expiration before approval. To my knowledge all biosimilars currently require a prescription in the US.

I also consider biosimilars to be the same principal as a me-too drug. I do understand the differences but dont think it is relevant to this forum thread. Basically its a situation where a drug company is trying to milk as much money out of patients without needing to put in all of the work to create something new.
 
 
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