Have you ever heard the expression used in medical facilities generic drugs and wondered what it meant? This article will throw some light on this subject.
The research and development of a new antibiotic from when it is first imagined to when it is administered post-approval goes through the following process;
i. Preclinical Testing: (3.5 years)
ii. Investigational New Drug Application (IND) (about 30 days)
iii. Phase I Clinical Trials (about 1 year)
iv. Phase II Clinical Trials (at least 2 years)
v. Phase III Clinical Trials (average of 3 years)
vi. New Drug Application (NDA) (2.5 years)
vii. Phase IV Studies (goes on after approval and is usually the reason for repurposing a drug e.g., Viagra or recalling it after observed long term side effects e.g. Thalidomide)
All of this can take up to 12 years and cost about $2.8B (2013 figures) to complete. In fact, the odds of a drug that begins this process making it to the final approval is as low as 1:5000.
If successful, the pharmaceutical firm, promptly files a patent for the medication and received a license from a licensing body- the FDA for instance, to produce and sell this drug exclusively for a definite period of time (usually 20years) after which the formulation for this same drug is made available to other pharmaceutical companies and they are able to manufacture this same medication-active ingredient and sell under a name of their choosing.
The reason they get this license is to ensure that the company that invested resources into research and manufacturing this drug gets rewarded for their success and additionally to incentivize other drug companies to go into research for their own medications. This ensures that as antibiotic resistance continues to be a threat to health there will be constant supply of new medications that deal with the threat that micro-organisms pose to human beings.
So is there a difference between a brand-name drug and a generic medication? the short answer is not really. The active ingredient is the same in both the name brand and generic medication so the individual getting either will be getting the exact same active ingredient i.e. The chemical that makes the drug work. So for all intents and purposes, they are getting the exact same medication
However, because the person with the patent (the company the manufactured the drug initially) has done all the work they get to choose the filler, binder, and flavors and this becomes the only version of this drug that is in the market till the patent expires this give it significant name recognition. It is the effect of those inactive ingredients (fillers, flavors, and binders) that translates to the differences that might sometimes be experienced when these drugs are administered.
Furthermore, because most of the heavy lifting has already been completed and extensively vetted by the regulators for the holder of the patent, the manufacturers of the generic versions of these drugs simply take an already existing drug formula, find their own binders, fillers, flavors and sometimes colorings and are able to bring the dugs to the markets at a significantly lower production cost- this is why generic drugs are significantly lower in price as case in point; In the US, Generic drugs have saved
the US healthcare system $1.67 trillion in the last decade. According to Tattika, Medicare savings amounted to $77 billion and Medicaid savings of $37.9 billion. Generics account for 89% of prescriptions dispensed—but only 26% of total drug costs.
It is important to understand that not every drug has a generic variant because the patent given to the manufacturer is for 20 years and might not have elapsed. For some medications, the therapeutic range is quite narrow and it would be wiser to stick with the brand name medications, this is quite often the case with antiseizure mediations
In essence, when a person receives a generic variant of a drug, they are getting the exact same active ingredient as is present in the known brand sans the higher cost. It is not in any way less than the branded medications although from a governance perspective the amount of oversight by the regulator varies from country to country it is the exact same active ingredient and will give the exact same outcome when prescribed. So you are not in any way, getting a lesser drug- it’s like saying the fuel you get a filling station A isn’t the same as the one from filling station B.
References 1. “Cost to Develop and Win Marketing Approval for a New Drug Is $2.6 Billion,” Tufts Center for the Study of Drug Development, Nov. 18, 2024.