“Which is better between the generic and the brand name?” “I don’t want the generic. I want something effective” “Why are brand name drugs more expensive?” These are all legitimate questions to have when having to choose between the generic or brand name version of a drug. But rest assured! I will answer all of your questions concerning this matter.
- What is a generic drug?
It’s a copy of a brand name drug. It has the same active ingredient (a substance that has a biological effect on your system) in the same therapeutic amount as its brand name equivalent (see below for more details on therapeutic amount). The differences pertain to the inactive ingredients such as the colourant, flavour, and preservatives.
- The process of releasing a generic drug on the market:
- The brand name company develops a new drug.
- Once approved, the brand name company must publish all important information concerning this drug (making of the drug, indications, side effects, conservation, administration, etc.).
- Brand name company gets granted a patent for that drug for around 15 years (this patent allows the company to recover its significant investment in research and development).
- Once this patent expires, generic companies can copy the “recipe” published by the brand name company in order to make their own version of the drug with the same active ingredient.
- A generic drug must be approved by the FDA (in the US) or by Health Canada (in Canada). It has to meet the same strict federal manufacturing and quality control standards as its brand name equivalent (same efficacy, safety, purity, and production requirements).
- Once approved, a generic drug can be marketed…at a lower price than the brand name version.
- Why does a generic drug cost less?
The investment by a brand company is much greater than a generic company. Considering that it comes up with a new drug, brand name companies spend more money and time in research, development, and even the promotion of its new drug.
- Same therapeutic amount?
Earlier I mentioned that a generic drug and its brand name counterpart have the same active ingredient in the same therapeutic amount. What does “therapeutic amount” mean in this context?
It means that these two drugs (generic and brand-name) have to be bioequivalent. In other words, they have to affect the body in the same way. A generic drug has to demonstrate bioequivalence by delivering the same amount of active ingredient into a patient’s bloodstream in the same amount of time as its brand-name equivalent.
Bioequivalence is not assessed by only comparing the amounts of active ingredient in products and making sure that these amounts are the same. The comparison is mainly made through pharmacokinetics parameters, such as the peak and average blood level that drugs attain (pharmacokinetics: the drug’s journey process in the body – consists of 4 stages: absorption, distribution, metabolism and excretion).
It wouldn’t be of much value to just look at the amount of active ingredient in the tablet without knowing the levels that the drug attains in the body. The effectiveness and safety of a drug is linked to its blood concentration..
However, bioequivalence is not a fixed percentage (ex.100%).The international consensus is that the blood concentration of a generic formulation must be no less than 80% or more than 125% of the brand name formulation. It’s been determined that there’s no significant difference in effects within this 80-125% range.
The requirements are different for certain drugs which have a narrow therapeutic range. This category includes drugs for which small differences in dose or concentration can lead to potentially serious side effects or therapeutic failures. The bioequivalence range is stricter for these drugs (ex. 90-112%). Here some examples of these drugs: epilepsy medications, anti-rejection drugs, warfarin (blood thinner), etc.
If you want to watch a funny exchange between a patient and a pharmacist concerning generic and brand-name drugs, check out my Youtube video above.
For more fun and educational content, don’t forget to check out my Youtube channel and subscribe to it:
- Debunking a Common Pharmacy Myth: The 80-125% Bioequivalence Rule: https://www.pharmacytimes.com/contributor/timothy-o-shea/2016/06/debunking-a-common-pharmacy-myth-the-80-125-bioequivalence-rule?fbclid=IwAR0V21Vz7kDbl5mxs2L8r1YHevdQvM30pEMDkc97kwbcGDOBRRhypHyJuB8