John Tiong Jeh Lung
PhD, MPharm, RPh
Did you know that once the patent for an innovator medicine (original brand) held by the innovator company (original inventor) expires, generic drug companies can manufacture and market the same medicine under different brand names (often referred to as generic medicines)?
This explains why you may sometimes see numerous brands of the same medicine dispensed to you either by your doctors or pharmacists. In case you missed it, please read Medicine facts (Part 1): Brand name vs active ingredient.
The World Health Organization (WHO) defines Generic Medicine as:
“A pharmaceutical product usually intended to be interchangeable with an innovator product that is manufactured without a license from the innovator company and marketed after the expiry of the patent or other exclusive rights.”
In short, a generic medicine is a product that is equivalent to innovator medicine in terms of strength, dosage form, route of administration with the same active ingredient, manufactured by the generic drug company after the expiry of the patent granted to the innovator company.
Are generic medicines really less effective and of lower quality compared with innovator medicines?
Given the familiarity of the general public towards the innovator medicines (because they have been around in the market for years before the availability of the first equivalent generic), it is not difficult to understand the scepticisms towards the latter. Moreover, some patients may also become uncomfortable with the sudden change of brand and appearance of the medications they have been taking for quite a while. In this context, generic medicines are often perceived as being less effective and of lower quality compared to innovator medicines. Inexplicably, it has been scientifically shown that a person’s perception can sometimes also affect the drug’s effectiveness in one’s body. This is known as the placebo effect.
It is worth noting that generic medicines are subjected to stringent regulatory control by regulatory authorities where generic manufacturers are required to meet the stipulated standards for safety, quality, effectiveness and identity to the innovator medicines. Generic medicines which do not meet these regulatory standards will not be registered by regulatory authorities worldwide (including the National Pharmaceutical Regulatory Agency in Malaysia) therefore, can never be marketed. This is important to safeguard the health, safety and well-being of the general public.
But why are generic medicines cheaper than equivalent innovator brand?
The main reason why innovator medicines are more expensive than their equivalent generics is due to the huge investment required for the drug discovery and development process. The entire process may take up to approximately a decade with a whopping cost in the range of hundreds of millions up to billions of dollars.
Factoring in the duration of the granted patent (and whatever that is left after the lengthy process of drug discovery and development), the innovator company has to price its product in such a way that it can make a reasonable profit in order to stay economically viable. This is important to spur more innovations by pharmaceutical companies to ensure the availability of medicines in the future for the treatment of different diseases.
With the drug discovery and development, manufacturing process, as well as other important aspects of the medicine already established by the innovator company previously, a generic medicine company does not have to go through the same lengthy and expensive process all over again. However, it is important for generic company to prove to the regulatory authorities that its product is equivalent to the innovator medicine in all the important standards and aspects mentioned previously. This requires relatively less costly trials such as bioequivalence studies (to ensure equivalent levels of drug absorption) of significantly shorter duration. As such, a generic medicine company is able to market its product at a much lower price point.
Why are generic medicines important?
Generic medicines are important to facilitate the provision of affordable and good quality healthcare to the masses. In fact, generic medicines have been widely utilised in many countries (such as the UK, USA, Canada and Australia) since they are cheaper and have been shown to be equally effective in treatment of diseases.
It is therefore important for everyone to be empowered with the right knowledge pertaining to generic medicines. This can help to dispel the “cheaper means inferior” misconception. That being said, it is always advisable to speak to your doctor or pharmacist if you are in doubt particularly when you are considering a switch between different brands.
- WHO (2016) Generic Medicines. WHO Drug Information 30(3): 370-375.