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Sunday, 1 May 2016

Branded & Generic Medicines



Branded Medicines vs Generic Medicines
Many medicines have its branded and generic products. Thus, they may cause confusion as different products’ names may actually be referring to the same medicine.




What are branded and generic products?
Branded products are
ü  innovator products which have undergone clinical trials (research studies in which the participants are assigned to one or more health interventions to evaluate the outcomes of the interventions).
ü  products with the patency protections (patents protect drugs from copycat versions for 20 years after the medicine is invented) before the manufacturing of generic products.
ü  more costly. 

Generic products are
ü  the copycat versions of the branded medicines which are as effective as the branded medicines.
ü intended to be used interchangeably with the branded products.
ü manufactured and marketed after the expiry date of the patent or other exclusive rights of the branded products.
ü cheaper than branded products.



What may be the differences between branded and generic products?
ü Different appearance of the medicines in terms of shape, size, colour and/or packaging.
ü Different inactive ingredients (ingredients without any medicinal effect) such as flavoring, colouring and preservatives. However, the safety of the inactive ingredients must be approved by US Food and Drug Administration (FDA).



How do we differentiate between the branded and generic products as a consumer?
Branded and generic products can be differentiated by looking at the manufacturer or pharmaceutical company that manufactures the product. Generally, products manufactured by those popular leading pharmaceutical companies such as Pfizer, Roche and Johnson & Johnson are normally branded products. Small pharmaceutical companies often manufacture generic products.



Why are generic products cheaper? Does cheaper means low quality?
ü  Generic products are cheaper as the manufacturers are not required to repeat the clinical trials which are costly and time-consuming.
ü  Several companies are often approved to market a single product and this creates a competition in the market which results in cheaper price.
ü  Cheaper does not mean that their quality is low.



Which product is better?
Both branded and generic products are supposed to be the same (bioequivalent). Generic medicines should work in your body the same way and in the same amount of time as the branded drugs. The generic products can only be approved if they meet the standard set by the FDA. Thus, generic products are safe to be taken.

Generic products approved by the FDA will be the same as the branded products in terms of their:
ü  Active ingredient (ingredient with medicinal effect)
ü  Strength
ü  Dosage form (for example, pills, inhaler or liquid)
ü  Route of administration (for example through oral, injection, inhalation or rectal)



Example



Should I buy a branded or a generic medicine? How do I choose?
Generic products are not available for all medications. Basically, both the quality and effectiveness of the branded and generic products are the same, except some rare medications that will be described in the next point. The following are the important points that we should consider before choosing a product:
ü  Allergic to any inactive ingredient
* Avoid using the product that contains the inactive ingredient which may cause allergy.
ü  Price
* Choose a product within your budget.



Can I switch to a generic medicine if I have been using branded medicine?
You can switch from a branded medicine to a generic medicine as they contain the same active ingredient and they are approved by FDA. In rare cases, generic medicines may have different health and medicinal effects from their branded medicines. Thus, it is important to stay on the branded medicine. In the following cases, the same prescribed medicines should be continued.
  •    Epilepsy medicines
  •    Medicines with modified-release dosage form as the absorption rate of the medicine has modified
  •    Mesalazine: To treat ulcerative colitis ( an inflammation condition of colon). Different products have different absorption rates.


If you are not sure of medicine switching, please consult your doctor or pharmacist.

Make sure to tell your doctor if you notice any changes in your condition or any unusual side effects when switching your medicine from a branded to a generic drug.



Author:
Loh Pui Yee
B Pharm (Hons) (IMU)

Editors:
Lau Hie Hie
B Pharm (Hons) (IMU)

Jamie Lim Jo Shin
B Pharm (Hons) (IMU)

2 comments:

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