Generic Drugs - What Are They?

A generic drug is a replica of an original brand-name drug that is allowed to be produced by a manufacturer rather than its originator, when the patent of the brand-name drug expires, provide it matches the bio-equivalence of the original drug. In other words, the pharmacological profile of the copied drug shall be the same as that of its brand-name counterpart, i.e., same intended use, effects, side effects, route of administration, risks, safety, and strength. Patents give the innovating manufactures exclusive privilege to sell the new drug in order to allow them to earn back its voluminous investments in creating a NCE (new chemical entity). It is estimated that launching a NCE requires investments of around US1 billion throughout the stages of R&D (research and development), manufacture, clinical trials, and marketing. As the patent nears expiration, manufacturers can apply to the FDA for permission to make and sell generic versions of the drug. Without the costs involved in the development of a new drug, the manufacturers of generic drugs are able to produce and sell it way more cheaply than its original. When multiple companies begin producing and selling a drug, the competition among them forces the price down even further. The cost factor is the driving force for the consumer to opt for generic drugs, and the impact of that has been a determinant factor shaping the landscape of the global pharmaceutical industry.

Some Misconceptions

There are some misconceptions about generic drugs, and the major one is that they are less safe than brand-name ones. The fact is that all generic drugs are reviewed and approved by the United States Food and Drug Administration (FDA), or, in other countries, by an equivalent federal regulatory agency. The regulatory boards in Canada, India, Israel, Chile, Australia, and the UK all require that generic drugs have the same active ingredients, quality, strength, purity, and stability as brand name drugs. They also must have the same dosage form – whether you swallow it (pill/tablet/capsule/caplet), drink it (liquid), or inject the medication. Sometimes, generic versions of a drug have different colors, flavors, or combinations of inactive ingredients than the original medications. Trademark laws in the United States do not allow the generic drugs to look the same as their brand-name counterparts, but the active ingredients in both must be the same to ensure no difference in therapeutic effects. Noteworthy is that not only the medications are abide by regulatory standards, but also the facilities where they are produced too. Therefore, it is also a misconception that generic drugs are manufactured in poorer-quality facilities, thus they are inferior in quality to brand-name drugs.

Another misconception is that new drug necessarily means better drug. This is not always the case. Experience has proved to many manufactures that, after expensive investments on the development of a new drug, sometimes no significant breakthrough is achieved. The new medication works nearly the same as the old one. In such cases, the consumer would be better off with the well-known old drug that is substantially more affordable the NCE. However, in cases when the condition being treated is a moving target where resistance patterns change over time, like cancers and infections, innovation is a must.

State Of Affairs

All in all, the use of generic drugs worldwide is growing annually by 14%, which is 8% faster than prescription, or branded products. The generic market today forms 75 per cent of the US pharmaceutical industry compared to 5 per cent in 1984. As a percentage of total prescriptions generic prescriptions stand at 47 per cent in the US (up from 18.6% in 1984), 49 per cent in Germany, 52 per cent in the UK, 40 per cent in Canada, 11 per cent in Japan, and 5 per cent in France (WHO 2004).

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