GENERIC DRUGS

 

What is a generic drug?

A generic drug is identical — or bioequivalent — to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price.

 

Are generic drugs safe?

Health professionals and consumers can be assured that FDA-approved generic drugs have met the same rigid standards as the innovator drug. To gain FDA approval, a generic drug must:

 

  > Contain the same active ingredients as the innovator drug (inactive ingredients may vary).
  > Be identical in strength, dosage form and route of administration.
  > Have the same use indications.
  > Be bioequivalent.
>

Meet the same batch requirements for identity, strength, purity and quality, and be
manufactured under the same strict standards of FDA's good manufacturing practice
regulations required for innovator products.

 

How are generic drugs marketed?

Drug companies must submit an abbreviated new drug application (ANDA) for approval to market a generic product.

 

Is it true that generic drugs are permitted to be different, if only slightly, than their brand name counterparts?

No, this is false. In fact, there have been studies in which brand name drugs were compared with themselves as well as with a generic. As a rule, the difference for the generic-to-brand comparison was about the same as the brand-to-brand comparison. Any generic drug modeled after a single, brand name drug must perform approximately the same in the body as the brand name drug. There will always be a slight, but not medically important, level of natural variability – just as there is for one batch of brand name drug compared to the next batch of brand name product.

 

GENERIC DRUGS VS. BRAND NAME DRUGS

 

How different is a generic drug from a brand name drug?

Through review of bioequivalence data, FDA ensures that the generic product performs the same as its respective brand name product. This standard applies to all generic drugs, whether immediate or controlled release.

 

All generic manufacturing, packaging and testing sites must pass the same quality standards as those of brand name drugs and the generic products must meet the same exacting specifications as any brand name product. In fact, many generic drugs are made in the same manufacturing plants as brand name drug products.

 

Why are generic drugs less expensive?

Generic manufacturers are able to sell their products for lower prices because they are not required to repeat the costly clinical trials of new drugs and generally do not pay for costly advertising, marketing and promotion. In addition, multiple generic companies are often approved to market a single product; this creates competition in the market place, often resulting in lower prices.

 

Are generics as effective as name brand drugs?

The generic drug manufacturer must prove its drug is the same as (bioequivalent to) the brand name drug. For example, after the patient takes the generic drug, the amount of drug in the bloodstream is measured. If the levels of the drug in the bloodstream are the same as the levels found when the brand name product is used, the generic drug will work the same.

 

FACT: Research shows that generics work just as well as brand name drugs.

A study evaluated the results of 38 published clinical trials that compared cardiovascular generic drugs to their brand name counterparts. There was no evidence that brand name heart drugs worked any better than generic heart drugs.

 

Are adverse effects of generic drugs monitored as closely as adverse effects of brand name drugs?

The monitoring of adverse events for all drug products, including generic drugs, is one aspect of the overall FDA effort to evaluate the safety of drugs after approval. Many times, reports of adverse events describe a known reaction to the active drug ingredient. Reports are monitored and investigated when appropriate. The investigations may lead to changes in how a product (brand name and generic counterparts) is used or manufactured.