The age old argument of Generic Vs Brand name drugs

[JohnBoy2000]

For Lexapro/Escitalopram - by example;

I'm looking at the binding ingredients - which are the only different ingredients - for the brand, vs the generic:

• microcrystalline cellulose
• croscarmellose sodium
• colloidal anhydrous silica
  magnesium stearate​
• hypromellose
• macrogol 400
• purified talc
• titanium dioxide

microcrystalline cellulose
croscarmellose sodium
colloidal anhydrous

silica​

magnesium stearate

hypromellose
macrogol 400​

titanium dioxide



For Effexor/Venlafaxine - brand vs generic:

cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide

​

sucrose, corn starch, hydroxypropyl cellulose, povidone K 30, ethylcellulose, dibutyl sebacate, talc​

The Lexapro ingredients are almost identical.

Effexor - I'm curious - seems several differences.

Anyone ever experienced any generic vs brand effect differences?

 

[sekio]

There's no question, generic medications are effectively identical to brand-name... the generic pharmaceutical industry has been around for many many years and has all the same requirements for QA/QC enforced by the FDA or equivalent. This includes tests where the pills are dissolved in simulated gastric fluid and the liquid tested after a certain time period to make sure the generic pills deliver the same dose in a similar amount of time.

Cellulose and its derivatives are pretty much exclusively bulking agents, they do not "hold on" to the active drug, so it should not matter if you have microcrystalline cellulose, ethylcellulose, hypromellose etc. Povidone is the same idea. Gelatine is a coating/capsule agent and iron oxide is for printing the lettering on pills/capsules.

 

[JohnBoy2000]

So by example in the cases where you read reports of people switching from brand to generic and having breakthrough symptoms - or occasionally there's bad reaction to binding ingredients like lactose, which is self explanatory but - in cases where there is breakthrough symptoms, what do we attribute that to?

A poor generic batch?

 

[d1nach]

Peoples self reports can not determine if two pills deliver equivalent mg of a drug.

Self reports are extremely unreliable.

 

[JohnBoy2000]

Peoples self reports can not determine if two pills deliver equivalent mg of a drug.

Self reports are extremely unreliable.

https://www.sciencedirect.com/science/article/pii/S0149291803801571


Results: Few publications compared the bioequivalence and efficacy of brandname and generic psychoactive drugs. Those that were identified revealed differences in the efficacy and tolerability of brand-name and generic psychoactive drugs that had not been noted in the original bioequivalence studies.

Specifically, l study found that plasma levels of phenytoin were 31% lower after a switch from a brand-name to a generic product.

Several controlled studies of carbamazepine showed a recurrence of convulsions after the shift to a generic formulation. After a sudden recurrence of seizures when generic valproic acid was substituted for the brand-name product, an investigation by the US Food and Drug Administration found a difference in bioavailability between the 2 formulations.

Statistically significant differences in pharmacokinetic variables have been reported in favor of brand-name versus generic diazepam (P < 0.001).

Finally, a case report involving paroxetine mesylate cast doubt on the tolerability and efficacy of the generic formulation.Conclusion: The essential-similarity requirement should be extended to include more rigorous analyses of tolerability and efficacy in actual patients as well as in healthy subjects.


I get the generic equivalence argument - but there's so much information out there as to an actual lack of equivalence...

 

[Volvak]

There are differences between brands and generics. That?s not a comment on the opening post of the OP.

The amount of the active substance can vary, the excipients can vary, quite possibly other things as well. Can you always trust a manufacturer ?

 

[sekio]

Can you always trust a manufacturer ?

When the FDA audits your facility and will shut your ass down for doing effectively any corner-cutting, if you're not producing generic drugs that are proven to be equivalent, you won't last long in the pharma game.

Here's a sample of a FDA warning letter. Note that they don't fuck around at all.

 

[nAON]

I heard once that the +/- tolerance of dose variability is far less stringent when it comes to generic medications.

 

[d1nach]

Im talking about mgs. Im too lazy to care about peoples subjective feelings or reports. Good luck though.

 

[d1nach]

*** sorry if that came out rude. No intention just half awake.

I guess what i mean is i have never experianced a large enough difference between brand and generic to not just go by the mg of the drug as the amount of research id have to do to find out any possible difference would be enormous.

 

[clubcard]

There's no question, generic medications are effectively identical to brand-name... the generic pharmaceutical industry has been around for many many years and has all the same requirements for QA/QC enforced by the FDA or equivalent. This includes tests where the pills are dissolved in simulated gastric fluid and the liquid tested after a certain time period to make sure the generic pills deliver the same dose in a similar amount of time.

Cellulose and its derivatives are pretty much exclusively bulking agents, they do not "hold on" to the active drug, so it should not matter if you have microcrystalline cellulose, ethylcellulose, hypromellose etc. Povidone is the same idea. Gelatine is a coating/capsule agent and iron oxide is for printing the lettering on pills/capsules.

Have you read about the FDA having to order the withdrawal of generics that they approved without ensuring the manufacturer had actually tested equivalence? I recall 400mg SR bupropion causing seizures due to dose-dumping and some overactive SR oxycodone brands that were in effect useless?

OK, I fully appreciate how hit and miss approved SR formulations are in general, but simply asking the maker rather than testing or at least reading the makers test data is far from best practice. I clearly recall fentanyl patches being all over the place and I had to tape the damned things on... it does look like commercial aspects are allowed to interfere with QC. If plain morphine worked for me, I would stick to plain morphine.

 

[vecktor]

When the FDA audits your facility and will shut your ass down for doing effectively any corner-cutting, if you're not producing generic drugs that are proven to be equivalent, you won't last long in the pharma game.

Here's a sample of a FDA warning letter. Note that they don't fuck around at all.

Unfortunately the FDA do fuck around when it suits them...
like when in 2012 the FDA audits a certain facility in Belgium, finds numerous areas of mold contamination in sterile production areas of an injectable product, the FDA then doesn't pull the license a cynic would suggest because the company is big and has big and ugly lawyers and several of those working for the FDA used to work for the company involved. In 2015 the FDA writes another strongly worded letter....nothing had really changed and the licenses still weren't pulled. in 2025 the company will be able to paper over all the mold with FDA 483s and still nothing will have changed.
The FDA's real purpose is not to protect the consumer its purpose is to protect the companies and further the expansion of the FDA.
There are plenty of examples of utter failures of the FDA and The EMA, enough to suggest it is not incompetence.