+33 64 94 75 259
Pharmaceutical companies still invest billions of dollars over several years in order to get their drug pipeline of product(s) approved, registered and patent protected to maximise profits from such brand ownership in a highly competitive global market. However, the revenue stream of a pharmaceutical company can be quickly impacted by the patent expiry of their prescription brand(s) owing to the competition of new generic medicines entering the market.
A generic drug is a copy of a brand-name drug that has exactly the same dosage, safety, use, strength, quality, performance, effects and side effects. These drugs are developed by other pharmaceutical companies once the patent for the original product has run out and the pharmaceutical company who developed the original (branded) medicine no longer has the exclusive right to produce and distribute the medicine.
Generic drugs contain the same active ingredient which acts to cure the condition the medicine is used to treat in the same quantity as a branded drugs. Some generic drugs contain different inactive ingredients that give the product its characteristic taste, shape, texture and smell. These inactive ingredients are intended not to affect the body in anyway, so essentially the drug performs the same function as a branded drug even though they look different. However, sometimes pharmacovigilance operations are set up to monitor any adverse events e.g. allergies arising from inclusion of new inactive ingredients.
For a generic drug to successfully enter the pharmaceutical market, it must be bioequivalent to the branded drug. This means that the clinical efficacy of the generic drug in the human body must be the same as that of the branded drug. The two types of medicine need to have similar absorption, distribution, metabolism and excretion. profiles This is why generic drugs must undergo rigorous bioequivalence testing in order for them to be approved for sale as generic medicines. Once a pharmaceutical company has successfully demonstrated that the generic product is bioequivalent to the original, it can produce and market the drug.
The main difference between generic and branded drugs is in the name. The names given to the branded drugs are the names given to them by the company for the purpose of advertising while the generic drug name is usually derived from the International Nonproprietary Name (INN) of the active ingredient that is the main composition of the drug. The International Nonproprietary Name (INN) is an official generic and non-proprietary name given to a pharmaceutical active ingredient. While the original drug brand names are usually capitalized, the other generic names may not necessarily be capitalised. Once the patent has expired on the original branded medicine, typically there is flurry of generic manufacturers to produce, register and market generic brands in competition against the original brand for the same prescriber market space. For example, the prescription medicine used to treat hyperglycemia in type II diabetes has the INN name “metformin” and one of the first brands adopted for the marketing of metformin was Glucophage. It was1957 when French diabetologist Jean Sterne as the first to try metformin on humans for the treatment of diabetes; he coined the name “Glucophage” (glucose eater) for the medication in his published work. Now 60 years on, metformin is sold under several generic trade names, including Glucophage XR, Carbophage SR, Riomet, Fortamet, Glumetza, Obimet, Gluformin, Dianben, Diabex, Diaformin, Siofor, Metfogamma and Glifor, to name just a few.
The major advantage of generic drugs is that it’s reimbursement (prescription) price compared to the branded drug one, tends to be much lower. The low cost can be attributed to the generic pharmaceutical manufacturer not requiring investment capital in research, testing and marketing of the drug. When the patent-protected time is over and generic drugs are approved, any pharmaceutical manufacturer can legally manufacture and sell a drug with the same ingredients as the branded one hence creating greater competition. Furthermore, bioequivalence trials are not as costly as clinical trials particularly for the phase I first in human testing, thus clinical development costs of generic drugs tend to be considerably lower.
The biggest disadvantage of generic drugs is the consumer confusion over the new and relatively unrecognisable generic brand being sold to them. Most patients don’t really understand the similarities and differences between generic and branded medicines and this makes it difficult for them to purchase the new lower priced generic branded medicine. They wonder if the quality and effectiveness have been compromised to make them less expensive than the brand-name versions.
The generic pharmaceutical industry is growing, and these medicines are likely to become more common in every country. Distribution in some countries is supported by their governments who encourage the use of generic medicines because they are often more affordable than brand-name medicines. Due to the high cost of branded drugs, most patients can’t afford the full dosage of the branded medicine hence in some cases end up not completing the prescribed dosage. This is why some doctors prescribe generic medicine to their patients and in Kenya for example, insurance companies encourage their clients to use generic medicines.
However, generic drugs should not be confused with counterfeit medicines, which are illegally manufactured copies that may or may not contain the same active ingredient.
A branded drug is the original drug that has been developed by a pharmaceutical company and given a trade name and also it’s protected by a patent. This means that the pharmaceutical company can solely produce and sell the drug until the patent-protected period is over. Once the period is over, other pharmaceutical companies are allowed to manufacture the Generic copies of the branded drug but they must not use the trade name of the original drug.
Before branded drugs are allowed into the market, they must undergo and pass rigorous tests and evaluations to ensure that it is both effective in curing the condition it claims to treat and safe for human use. Since a lot of money is invested in developing this new drug, the pharmaceutical company is given the sole right (patent) to manufacture and distribute the medicine for a period of time. This will mean that the medicine belongs exclusively to the company. For this reason, branded medicines are the most well known and most trusted type of that particular medicine.
Branded drugs are very costly because the pharmaceutical companies need to recover the amount of money used in research, development and marketing of the drug. So when one purchases the drug, they are also paying for the research costs, the costs incurred in proving it is safe, the costs to market and transport the drug.
In conclusion, the generic drug market is here to stay and is actually expanding for most treatment areas. owing to the considerable cost saving benefits for the patient to achieve the same clinical outcome if not better, as highlighted above owing to better patient compliance. Although generic drugs are highly recommended in some countries, consumers need to be educated on the inactive ingredients contained in them in order for them to circumvent the risk of adverse events.