4.2.1. Definition of Generic Drug

In simple words, a generic drug is a copy of an originator/innovator drug or brand name medication. Per definition the generic drug has to be equal in quality, strength, safety, pharmaceutical form (tablet, liquid, capsule, etc.) and it must have the same intended use as the originator drug, i.e. it has to be used for the same indication. In other words, “a generic must contain the same active ingredients as the original formulation... Generic drugs are identical or within an acceptable bioequivalent range to the brand name counterpart... Therefore, generics are considered identical in dose, strength, route of administration, safety, efficacy and intended use... generic products are available once the patent protections afforded to the original developer have expired. When generic products become available, the market competition often leads to substantially lower prices for both the original brand name product and the generic forms.”⁴⁶

Besides the high competition, which starts right after the patent expiry, generic drugs are also less expensive, as the manufacturers of generics do not have to invest in the very cost intense research and development of a new drug. All in all generics make medication affordable to more people.

Before generic drugs can be sold and marketed, they have to be approved by the regulatory authorities in the same way as originator products. There are regulatory bodies at a national level like the PEI and the BfArM in Germany and also more internationally active and powerful authorities such as the FDA for the USA and the EMA. These registration and approval processes are the guarantee for quality and efficacy of any innovator or generic drug and are strictly supervised from these official institutions on national and international level.

⁴⁶ http://www.news-medical.net/health/Generic-Drugs-What-are-Generic-Drugs.aspx [16 May 2013]