Are generics really the same as branded drugs? (Explanation by Dr JB Lim)

The blogger’s note: In response to the article entitled “Are generics really the same as branded drugs? “ (Refer: http://management.fortune.cnn.com/2013/01/10/generic-drugs-quality/ ), the Great Sifu Dr JB Lim explains as follows:

From: lim juboo

Sent: Wednesday, June 05, 2013 12:30 AM

Thank you for this information. It came as a surprise to me.

I represent my drug company that produces a lot of generic drugs for hospitals, as well as herbal medicines, nutritionals, cosmetics, and other health-care products.

Allow me to give my qualified professional opinion on this issue between a patented drug, and a generic drug.

A patented drug is the original drug produced by a drug company and has been patented.

A generic drug is one reproduced by other drug companies after its patent rights of the original company have ended. This can only happen after the patented drug has been in the market for about 20 years.

This takes place only after the final phrase of clinical trials has ended and the drug has been approved by FDA for use by the medical profession. The clinical trials may take as long as 8 – 10 years.

To the best of my knowledge and understanding in pharmaceutical chemistry, and in clinical pharmacology, whether it is the original branded drug, or the generic copy, both are exactly the same in their molecular formula, molecular configuration, molecular weights.

A generic drug will exert exactly the same pharmacodynamics (mode of action) and pharmacokinetics (mechanisms of absorption, its rate, distribution, retention, as well as in its metabolism) as the patented ones.

Else, there is completely no difference between a branded patented drug and a generic one since both bear exactly the same molecular and empirical formula.

A simpler way of putting it, both are exactly bio-equivalent with each other in clinical efficacy, safety, and in performance characteristics provided it is administered in the same strength (dosage), and via the same route for that intended clinical use.

You may say that a generic drug is exactly a clone copy of the original branded drug. That is the simplest way I can defined it in one sentence.

What is different is the enormous disparity in price since a drug company which originally formulated and developed the original drug would have spent up to 25 years in research, drug designs, exhaustive experimentation, repeated bioassays, and toxicity studies.

After these pre-clinical protocols, it has to undergo a few phrases of clinical trials before they can put the drug into the market. You can imagine the horrendous amount of money, research, and time put into it in R&D.

In the process of R & D, they would have pumped in no less than $250 million as in the late 1980, to a whooping US $ 40 thousand million currently.

This is just to develop a single drug. The amount spent naturally will depend on the complexities of research and drug design.

Do you think a drug is going to let this go cheaply even after its patent rights has expired?

Of course not! They will try to protect their R&D by claiming that the generic ones manufactured by other pharmaceutical companies are not as good in clinical efficacy as the original ones.

It is only after their patent rights has ended over such a short period between 10 – 20 years (depends on the country where the patent rights was filed) that other drug companies try to clone it so very much cheaply.

No government anywhere in the world will allow a drug manufacturer to produce a generic drug without following very strict regulations, quality and safety control, and strict GMP (Good Manufacturing Practice) standards as those for patented ones.

Both will come out the same way in physiological, pharmacological actions, and therapeutic efficacy.

It is so obvious there are a lot of economical reasons behind this. The original company just wants to make a lot of money before its patent rights ends, and after that as well.

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I think the original drug companies which produces branded drugs in this article wants to persuade the FDA to influence the medical profession on “their drug of choice” to protect their formulation by making such claims.

jb lim

The Dynapharm Pharmaceutical Group

Malaysia