According to the WHO, 30% of the world population does not have access to the essential medicines, and the estimated figure is 50% in some countries of Africa and Asia. High prices of medicines make it unaffordable. Hence there is a need for affordable and effective medications.
When a physician prescribes you a medicine, you might have been asked if you are comfortable with a generic alternative. It is essential to understand the difference between generic and brand medicine to make the right choice. A generic drug is a medicine which is the same as the branded one in its dosage, use, quality, effect, and active ingredients. There might be slight changes in their shape, color, and taste. Here is a comprehensive guide about generic medicines, how they differ from branded ones, and their safety precautions you need to know.
What are Generic Drugs?
Medicines have two names:
- The brand name, coined by the pharmaceutical company which has been innovated and has a patent and manufactures it
- The generic name, the drug which has the same active ingredient as the brand drug and makes it work with less price
According to the WHO, A generic drug is meant to be similar to an inventor product, is produced without a license from the innovator company, and is sold after the expiry date of the patent. According to the FDA, generic medicine can be defined as a drug product that is as same as that of a brand medicine, in dosage, strength, active ingredients, composition, quality, and route of administration (1).
Global healthcare expenses are rapidly increasing, and the utilization of generic medicine is encouraged as it is less expensive than brand drugs. It also has similar properties and effectiveness as that of the brand drug.
Generic medicines are different from the brand versions in some properties, such as:
- Size, color, odor, taste, and shape
- Inactive ingredients which do not contribute to the treatment effect of the medicine (2)
Do Generic Medicines Work the Same as Brand-Name Medicines?
Yes, they work in the same way as a brand drug since they contain the same active ingredient and dose as that of the brand drug.
A generic medicine is the same as brand medicine in dosage, safety, effectiveness, therapeutic standards, strength, quality, stability, and mode of consumption. Every generic medicine developed after a brand-name drug must have the same metabolism as a brand-name drug in the body. They also have the same risk and side effects as brand drugs.
FDA persistently inspects drug products to make it safe at all levels of the supply chain. From the raw material, active ingredients to the final product sold to the consumer, these drugs are safe, effective, and of the best quality.
The generic medicine formulations might have some inactive ingredients causing some side effects. To avoid this, the WHO has drafted strict guidelines for testing the products based on internationally accepted references to prevent the distribution of low-quality preparations (3).
Why Generic Medicines Cost Less Than Brand-Name Medicines?
Generally, large pharma companies invest huge money in research and development of the products, new formulation of drugs, and sometimes profitable results are not assured.
When a company develops a successful drug candidate, they file a patent and preserve the company’s right to manufacture the medicine for at least five years. During this phase, the company sets the maximum profit.
The market for generic drugs opens when the patent expires. During this time, competition intensifies, and the price of the generic and brand name drugs decreases.
It is essential to understand that the generic drug generators only make the original drug’s exact duplicate. They do not invest money in research and development and clinical studies. The money is spent on marketing the product or creating a place in the market; hence they are sold at 80 to 85% less price than brand medicine. Competition between a brand drug and multiple generic drugs is also one of the reasons for competitive prices (4).
Are Generic Medicines Safe?
Any drug which is approved by the FDA is said to be safe. Both brand name drugs and generic drugs work well and are safe. Generic medicines are the same as brand drugs that use the same active ingredients; hence they have the same risk and benefits.
FDA-approved generic medicines are sold after the patent of the brand is expired. Once the FDA approves any drug, either brand name or generic medicines, it continues to examine the quality of treatment. It monitors side effects or any adverse reactions caused by the medication, and necessary actions are taken.
FDA persistently examines medicines that are developed by generic and brand. At all levels of the supply chain, from active pharmaceutical ingredients (APIs) to products being sold to consumers, are safe, effective, and are of high quality (9).
Visit Drug Quality Sampling and Testing page to understand the FDA’s efforts to ensure the regulatory standards for brand-name and generic medicines.
Follow the Guidelines While Choosing a Generic Drug
It's essential to understand a few facts and follow guidelines when considering generics:
1. Compare the Formulation of Generic Medicine With Brand Medicine in Orange book FDA
You can search for your prescribed generic drugs on the orange book’s prescription or over the counter drug list using its brand name or active ingredient. You can also use the ingredient search to check out all the approved FDA medicines which contain this ingredient.
Generally, pharmacies substitute only the FDA-approved generic drugs with the prescriber’s and patient’s permission.
If you are willing to use brand drugs, you can always ask your doctor for brand drugs (5).
2. If you Notice any Changes or Side Effects When you are Switching to Generic Drugs Report to Your Doctor Immediately
If you are experiencing any discomfort like nausea and dizziness after switching to a generic drug, then report immediately to your doctor.
FDA allows around 5- 10% difference between the brand and generic drugs in inactive ingredients. It has been calculated the brand-generic switch shows clinical improvement in 30% of people, 30% remain the same as the brand drug, 10% have some side effects, and 30% may experience reduced clinical efficacy (6).
It is important to notice such changes and report to your doctor when you switch from brand drug to generic and one generic drug to another generic drug.
3. Ask Your Doctor the Rate of Absorption of the Drug
The studies have reported the presence of inactive ingredients/excipients in generic drugs, which may differ from one formulation to another. This might influence gastrointestinal transit, absorption, solubility, and stability of active substances.
These excipients are also related to the loss of response during the treatment with generic drugs. Excipients affect gut transport and overall drug absorption; this affects systemic levels of drugs. In a few reported cases, this has increased mortality risk in patients with cardiac arrhythmias after the switch between brand to generic or generic to generic.
Hence it is crucial to understand and know the composition of the drug (7).
4. Check the Inactive Ingredients in a Generic Drug.
Check the drug’s composition if you are sensitive to any ingredient; you may experience ill-effects with whichever formulations contain it, either brand or generic. In case if you are lactose intolerant, better do not take lactose formulated drugs. If you are sensitive to gluten and dyes, avoid those contents. Talk to your doctor if you are sensitive to any ingredients for alternative options (7).
5. Know the Composition of Over-the-Counter Generic Drugs
OTC drugs taken for stomach ache, headache, and arthritis are confused easily. It is essential to know the nonprescription generic products contain the same amount of active ingredients that of brand drugs.
6. Check for the Price on Your Medicine
Generally, the price of generic drugs is ten times less than that of brand drugs. Generic medicines are less priced compared to the brand name drugs because they do not invest in research and development.
Federal trade commission (FTC) says that some drug companies have used a policy known as “pay-for-delay,” where generic drug companies are paid to keep their low-cost alternative drugs off the market (8).
The organization has filed some lawsuits and is looking forward to legislation to stop pay-for-delay deals.
Final Words
Generic drugs and brand drugs work in a similar manner. Generic drugs make the medications affordable to all. Talk to your doctor about generic drugs and their equivalents of any brand drugs that you are taking.
If you are sensitive to any drug ingredient, inform your doctor. In case if you switch to generic and experience any side effects, report immediately to your doctor.