What Is A Generic Drug?
Most people might have heard about generic drugs at pharmacies or on TV, which the Ministry of Health, Labor and Welfare (MHLW) has promoted to use to reduce the burden of medical costs on patients and to improve medical insurance finances. There are also some generic drugs in veterinary medicine, so let me explain them briefly.
A generic drug is a pharmaceutical drug which obtains manufacture and sales approval as therapeutically equivalent to an original drug. It’s sometimes called a me-too drug, and an original drug is called a brand-name drug.
An original veterinary drug is generally given patent protection for six years as the drug is re-examined. The period of patent protection can be further extended. The approval of generic drugs is not permitted during the reexamination period. In other words, generic drugs must produce the same data as original drugs in order to gain approval. Patent protection is given to companies which develop new drugs because they need to retrieve some of the enormous costs involved in developing the drugs.
Do you think that a generic drug is exactly the same as an original drug? –The answer is ‘No.’ The active ingredient is the same however, each drug contains various ingredients for sustained release properties or stability. Thus, all the ingredients are not always the same between the original and the generic drug. That is why some doctors value the original drug, whereas MHLW promotes the use of generic drugs.
By the way, let me explain what kind of data are needed to obtain the approval of generic drugs. In veterinary drugs, three types of data are required: specification of the formulation, stability data for the determination of shelf life, and bioequivalence studies to confirm the same therapeutic effectiveness as the original drug. Thus, the company which applied for approval of generic drugs has no basic data such as the safety and the efficacy.
In general, owners of companion animals rarely receive explanations about generic drugs by veterinarians when their pets are given drugs, however, we hope you understand that veterinarian drugs also have generic drugs like human drugs.