Generic drugs have the same chemical composition and non-active components as their brand name counterparts. Generics are prescribed in the same dosages, are administered in the same forms and act the same ways in the body. The difference to the consumer is the price. Generic drugs usually cost much less than the brand name product.
Pharmaceutical drug development costs for generics are much lower than for brand name drugs because it is not necessary for them to conduct the extensive studies required of new medicines; they only asses the bioequivalence of their generic product to the brand name product. Producers of generic drugs still make a profit even though they sell their drugs at a much lower price than the brand name product.
Application for pharmaceutical drug development of generics is easier and less costly than for a new drug
When the patent for a brand name drug expires, other pharmaceutical manufacturers may develop their own generic forms of that drug. FDA approval is still required for the production and sale of generics, but this approval is through an Abbreviated New Drug Application,?ANDA. It is a much quicker application process as it has?has fewer requirements than does an application for a new brand name drug.?Thus, the ANDA is faster to review and approve by the office of Generic Drugs.
Here are a few reasons why pharmaceutical drug development for generics is easier and less costly than in the development of new drugs:
- The chemical composition of the drug has already been established by the brand name company so there are lower costs incurred for research and development.
- Generic companies need only show bioequivalence. They are not required to conduct costly clinical trials to prove the safety of their generic drug or that the drug works in the way it is intended to work. These trials were conducted by the brand name company.
- Companies producing generics must prove their product is biologically equivalent to and performs in the same way as the brand name drug. This means the generic version has the same active ingredients delivered into a patient?s blood stream in the exact same manner and the exact same time as does the brand name drug.
- The generic drug must not look like the brand name drug. For example, it must have a different color even though its chemical composition must be the same.
- When the application is approved, the cost to the generic pharmaceutical company is limited to costs of producing and distributing the generic drug.
Other advantages of pharmaceutical drug development of generics
FDA approval of an application for production of a generic drug signifies that the drug has met the ?same rigid standards? required of the brand name drug manufacturer. ?The FDA approval of the ANDA signifies the generic has been shown in limited clinical studies to be as safe as the brand name drug and works in exactly the same way.
Pharmaceutical companies that manufacture generics actually receive the benefit of the previous marketing campaigns of the brand name company. The public is familiar with the drug and is comfortable using it. When competition is presented by multiple companies now offering the same drug in just a cheaper version with a generic name, consumers are more likely to demand the less expensive drug.
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