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Generic Biotech Drugs

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Welcome to Generic Biotech Drugs. A generic biotech drug is a drug which is produced and distributed without patent protection. The generic biotech drug may still have a patent on the formulation but not on the active ingredient. A generic must contain the same active ingredients as the original formulation.

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By extension, therefore, generics are considered (by the FDA) identical in dose, strength, route of administration, safety, efficacy, and intended use. The FDA’s use of the word identical is very much a legal interpretation, and is not literal. In most cases, 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. The time it takes a generic drug to appear on the market varies. In the US, drug patents give twenty years of protection, but they are applied for before clinical trials begin, so the effective life of a drug patent tends to be between seven and twelve years.

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The History of Generic Drugs

The History of Generic Drugs

The history and the story of generic drugs is very long. But as a layman, all we need to understand clearly is that these generic drugs are nothing but “general drugs” or you can say cheap representation of original drugs. Basically to make a drug requires years of research in the laboratory first and then once prepared the drug has to undergo many clinical and market tests. All in all to put it the entire point from the point of view of consumer, the process of drug making is not only hugely time consuming but also very – very expensive.

Before these drugs are launched in the market, they need to have a patent. There after they are presented before the market for sale. The problem with these drugs is that they are exorbitantly priced for the company has to make for all the investments it did for the drug. It is at this juncture that the Generic drugs come to the seen.

Generic drugs do not have patent protection and that makes the generic drugs cheaper because they don’t have to waste time and money in patenting process. Generic drugs though maintain the original formula and active ingredients of the originally researched drug. Generic drugs just take a short cut to patenting process and the research process and these two factors make all the difference in the cost of the generic drug.

For the consumer, generic drugs are a boon. Economically weaker section of society that also includes a large percentage of older population is hugely benefited by the generic drugs. These generic drugs have the same composition yet are much cheaper than the original drugs. Being affordably priced these generic drugs can be easily purchased by the economically weaker section of society who would have otherwise ailed through the illness due to costly drugs.

Generic drugs are identical to the original drug in all aspects, be it dose, strength or effect. Generic drugs have a hugely competitive market and this in turn is beneficial for the consumers in the form of reduced prices. Generic drugs are the bio equivalent version of original drug. This simply means that they are identical in composition and formulation to original drug. Generic drugs are not much different than the brand named drug, except actually the brand name. In fact generic drugs are much more common and widely used.

Generic drugs are a boon in disguise, both for the consumer and the

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