10 Important FAQs About Generic Medicines

Admin | 03 Mar 2021
10 Important FAQs About Generic Medicines

1. What are Generic Medicines?
A generic medicine is just the similar medicines that are marketed under a brand name, and they have the same strength, dosage, performance characteristics, quality, route of administration, safety and intended use. They have the bioequivalence, which means that a generic medicine performs in a similar way a branded medicine would do and provide the same clinical benefit just like the branded medicine. It is said that generic medication is an equal substitute for the branded name medicine.

2. Does generic medicine work just like the branded medicine would do?
Generic medicines do not compromise on the quality and ingredients and perform the same way as the branded ones in the body. All the generic medicines follow the standard. Safety, dosage, quality, effectiveness, strength, each aspect is taken care of in a generic medicine as it is with the branded ones. When I say so, it means that the generic ones have the same side effects and benefits as brand-name medicines. The generic medication meets the standards which are conducted by the FDA Generic Medicines Program where they inspect 3,500 manufacturing plants every year and monitor the generic medication or medicine safety after been approved and brought to the market.

It should be noted that whenever a generic or branded medicine is mass-produced, there is a slight level of natural variability, which is not medically important. The variability is because there might be one batch of the branded medicine compared with the next quantity of branded product. When these generic and branded medicines are mass-produced a very small variation in size, strength, purity and other parameters are permitted and the FDA limits that acceptable variability. In general terms, the difference that is seen in generic to branded one is the same as the branded medicines to branded medicines.

3. Why is the look of branded medicines different from the generic ones?
Though the generic medicines and the brand name one share the similar active ingredients, the trademark laws do not allow a generic medicine to look like the branded ones. Other characteristics like flavours, colours, safety, performance or effectiveness may be different, but they do not affect the workability of these medicines.

4. Why is the Cost of Generic Medicines Less Than the Branded Medicines?
The FDA conducts a rigorous review, and then the generic medicines are available in the market. The reason why the analysis is done is that just like new products are protected by patents and prohibit other products others to make copies of the same product, the same is with the generic medicines. The license prohibits because along time is put into for bringing a new medicine in the market, and this period helps the medicine companies to recoup the costs associated with the new medicine brought in the market. FDA also allows a certain period to the branded ones to market their medicine exclusively, thus prohibiting generic medicines not to produce their medication into the market. After the patents and marketing period ends, the generic medicines than get approval. The generic medicine can also get support if the generic medicine website company successfully challenges the patents.

Now, to tell about the cost of the generic medicines being less compared to the branded ones is because the generic medicines do not have to repeat the animal and clinical (human) tests that are conducted by the branded medicines for the safety and effectiveness. For this particular reason, the application is called an “abbreviated new medicine application.” The other reason why the prices are lower of the generic medicines is that multiple generic medicine website companies are often approved for marketing a single product and creates competition.

The generic medicines though having the same effectiveness as their branded medicines, they do not incur the upfront research cost and are sold at a discount of 80 to 85 per cent compared with the price of the branded ones.

5. What are the Standards that Generic Medicines Need to Meet FDA Approval?
The generic medicine website companies need to submit an Abbreviated New Medicine Application (ANDA) to market a generic medicine as the branded version, and the FDAs Office of Generic Medicines reviews the application.

In the following ways, the generic medicines can show that they are equivalent to the branded ones:

The generic medicine website companies must showcase their evidence that proves that their active ingredient is similar to that of the branded ones, and the FDA should review that evidence too.
The generic medicine has a similar strength as the brand-name medicine.
The product is the same that the generic medicine is made of like if the brand name medicine is tablet the generic medicine should be a tablet.
The route of administration should be the same (oral or topical).
The use of indications should be the same.
The generic medicine website companies must submit evidence that all the ingredients used in their products are acceptable, and the FDA must review the evidence.
The generic medicine website companies should do the stability test for at least the same amount as the branded ones.
The generic medicines should meet the same batch requirements for identity, purity, strength, and quality.
The generic medicine should be able to prove itself that every step of the manufacturing process will produce the same result every time. The FDA carries out this work.
The generic medicine website company must produce batches of the medicines for marketing and provide information about the manufacturing of those batches to be reviewed by the FDA.
There should be an appropriate container in which the medicine will be shipped and sold.
The medicine label that shows information for generic medicine should be the same as the branded medicine. There is one exception that if the branded medicine is approved for more than a single-use and protected by patents or exclusivities, then the information label can be different. The information for generic medicines can differ if the manufacturer of the medicine is changed like the lot number or company name can vary.
For the development of new medicines, the medicine companies are given patents and exclusivities, and that may delay FDA approval of applications for the generic medicines.
It is not necessary and needed by the ANDA process to repeat the expensive animal and clinical tests on ingredients or dosage forms already approved for safety and effectiveness. Now, allowing generic medicines to be brought to market more quickly and at a lower cost, allowing for increased access to medications by the public.

6. Is a generic version of my brand-name medicine available?
You can ask your local pharmacists for helping you to know if the generic medicine is available in place of the branded medicine, or there are three ways to find your generic medicine:
Look for Medicines@FDA, which is a catalogue of medicine products of FDA and includes their medicine labelling.
Use Orange Book
Search by brand name.
Search again by the active ingredient name.
If other manufacturers are listed beside the branded manufacturer while you search by the active ingredient, then they are the generic product manufacturers.
You can also consult the First Generics List for recent approvals.
Suppose you are unable to locate a generic version of your brand-name medicine. In cases, if you are unable to identify, it may be that the brand-name medicine is still within the period when it has exclusive rights to the marketplace, to allow medicine companies to recover their costs for the initial research and marketing of the branded medicine. It is only after both patent and other periods of exclusivity are resolved that the FDA can approve generic versions of the medicine.

7. Does the FDA monitor side effects or safety issues with generic medicines?
After approving any medicine, the FA continues to examine the safety of the medicine. The FDA undertakes several actions to ensure safety and quality before and after any new generic medicine is brought to market.

The staff of the FDA monitors the medicine products continuously so that at every level of the supply chain, starting from the active pharmaceutical ingredient (APIs) to consumers getting the products are in a safe hand, effective and with high quality.

FDA even monitors and investigates reports of negative patient side effects, and the investigation might lead to changes in how a product is manufactured or used.

8. Where can I find more information about generic medicines?
You can take the assistance of your doctor, pharmacist, or other health care providers for seeking information on the generic medicines. You can also, visit the FA Generic Medicines Program or call 1-888-INFO-FDA.

9. From where can I buy generic medicines?

You can even lookup for the online medicine applications where they offer great discounts on generic medicines and also gives the facility of doorstep delivery within 48 hours of placing your order.

10. Do we need prescriptions to buy generic medicines?
Through generic medicines contain the same properties as the branded counterparts, especially the active ingredient, but few active ingredients are regulated and thus require a prescription before the sale. Therefore, the generic medicines containing controlled active ingredient need an order before the purchase.