ADAKAH KITA BOLEH HAMIL KETIKA...
In light of the recent discussion between our Minister of Health Malaysia, YB Tuan Khairy Jamaluddin and former prime minister, Datuk Seri Najib Razak’s lawyer on the supposed change in his blood pressure medication due to a different brand (manufacturer), we wish to address some of the common misconceptions between generic and branded medicines that the public have in this article.
What are branded medicines?
Branded or also known as innovator drugs (medicines) are products that are newly discovered for a specific illness/condition. Once approved, the pharmaceutical manufacturing company who came up with such a drug would receive what is known as the patent market exclusivity right to prevent other companies from replicating the formula of the drug and selling it to the market. These patents are typically valid up to 20 years or more before they expire, in which the company will be given the benefit of producing and selling the drug under the agreed brand name to return the cost incurred and make a profit.
What are generic medicines?
After the patent expires, it would then be legal for anyone in the pharmaceutical marketplace to mass produce the similar drug according to the approved formula, which would then be known as a generic medicine. Generic drugs are actually not much different from the branded drugs; they are made of the same active ingredient (the chemical that produces the therapeutic effect), strength, dosage form and route of administration from the branded version.
For them to be approved as an acceptable and equal substitute, the generic drug manufacturers are required to perform rigorous testing on their drugs to prove and assure the Drug Control Authority (DCA) that their medicines are bioequivalent (works the same way) as the branded drug. In Malaysia, the DCA imposes strict evaluation and assessment for all medicines before it can be marketed to the public to ensure the drug’s quality, safety and efficacy are not compromised. Thus, a generic medicine that successfully passed the bioequivalent testing should have similar therapeutic effects as its innovator.
Image credit: JAMA Patient Page
Example of branded and generic medicines in the Malaysia market:
Some common examples of brand name and generic drugs can be seen today are for diabetes, hypercholesterolemia and hypertension (all of which are pretty prevalent nationwide). For instance:
How does the branded drug differ from the branded drugs?
The biggest and most notable difference between these two is their price. Many of us have less confidence in generics because its price can be up to 70% cheaper than branded drugs and cheaper things are often associated with poorer quality or weaker efficacy. But this statement is not accurate at all. As mentioned above, all necessary testing is mandatory to be carried out prior approval by the DCA and whatever that is approved should guarantee the drug’s pharmacological benefit for its intended purpose.
Why then you may ask that generic drugs cost so much cheaper than the branded ones? Generic drugs are essentially much cheaper than branded drugs because they do not need to account for high research and development costs involving expensive and time-consuming clinical trials that the innovator drug manufactures are subjected to. Besides, they are also free from the large sum of funds on advertising and marketing the drug since it's been existing in the market for more than 20 years and people have already used it for that long. Furthermore, generic manufacturers also create competition in the marketplace as more companies will be interested in producing the drug, further reducing the price.
On top of that, generic drugs may differ in terms of their shape (ie: oblong or round) or colour due to the different pharmaceutical inactive excipients (ie: dyes, flavouring agent, binders etc) that are added during manufacturing process for stability, preservation and consistency purpose. These differences technically do not affect the drug's therapeutic efficacy but are there for branding purposes.
How do I know that it’s the same drug?
According to the poisons law, all drug manufacturers need to list the active and inactive ingredients of a drug on its label. While drugs may have different brand names, the generic name generally describes the active ingredient of the drug and this is a way to identify if they’re the same as the branded version. However, when in doubt, you should talk to your doctor or pharmacists to avoid any unwanted medication error.
In a nutshell
Despite the difference in appearance between both branded and generic medicines, in terms of its pharmaceutical active ingredients, they are very much the same in both amount and quality. This also means their efficacy, quality and safety profile are consistent and the choice of choosing which drug would depend on individual patients’ preference and budget. It is also worth noting that the same active ingredient will have different brand names in different countries. With that said, patients are also advised to remember their drugs based on their active ingredients and their indication rather than solely by their brand name, shape, colour or even taste.
Written by Janelle Leong, Bpharm(Hons)
Medicines: branded versus generic - New Straits Times. Available at https://www.nst.com.my/lifestyle/heal/2020/07/612895/medicines-branded-versus-generic Accessed on 16th September 2022
Generic Drugs vs Brand Name Drugs: What’s the Difference? Available at https://www.healthworks.my/generic-drugs-vs-brand-name-drugs/ Accessed on 16th September 2022
Generic Drugs - JAMA Patient Page. Available at https://jamanetwork.com/journals/jama/fullarticle/2530539 Accessed on 16th September 2022
Generic Drug Facts - FDA. Available at https://www.fda.gov/drugs/generic-drugs/generic-drug-facts Accessed on 16th September 2022
Difference Between Brand and Generic Drugs. Available at https://www.rosemedicalgroups.org/blog/difference-between-brand-name-and-generic-drugs#:~:text=While%20brand%20name%20drug%20refers,as%20the%20brand%2Dname%20drug. Accessed on 16th September 2022
ADAKAH KITA BOLEH HAMIL KETIKA...
It's World Diabetes Day! 1...
Image credit: Alvesgaspar,...
Do you have that pooping s...
Whether a pregnancy test t...
A toddler blinking hard or fas...
Introducing DOC2US, Your Trusted Online Doctor. With its name synonymous to “talk to us”, DOC2US is a mobile application that allows you to talk to a doctor or any healthcare professionals via text chat at any time and from anywhere.