Labels don’t count, the drug does

by Dr Amit Jotwani

Differentiating between branded and generic medicines

When a drug is first released in the United States, its parent company sells the medicine exclusively under a brand name for a select number of years. This duration depends on how many years are left of the patent. Moreover, the type of exclusivity granted at the time of approval by the US Food and Drug Administration (FDA). When the patent or exclusivity runs out, other manufacturers can follow suit to produce the same medicine, thus making the drug generic and made available by multiple manufacturers. The generic version is often cheaper than the branded version, inviting a reputation of unreliability and the pervasive misconception that things of a generic nature are not as good as their branded opponent. This might be the case with thrift store supplies, but it may not apply to generic medicines. 

Here’s why. Before a company can manufacture and market a generic drug, they must submit an Abbreviated New Drug Application (ANDA) to the FDA. This application includes the information proving the generic product is a pharmaceutical equivalent and the bio-equivalent to the branded product. The pharmaceutical equivalent means that the generic drug contains the same drug compound as the innovator drug as well as the same strength, dosage form, and route of administration. Bioequivalence means that the generic product must have the same effect as the brand drug. The compound reacts in the same manner in the body, in the same amount of time as its branded version. 

However, the rub here is that even if the brand and the generic drug molecules have the same pharmaceutical and bioequivalence, it does not mean that they are the same in every other way. Substances called excipients are put in the drug molecules, which are inactive substances that are approved to bulk up tablets like lactose starch and microcrystalline cellulose as dilute ingredients. Other excipients may perform functions like helping the tablet disintegrate in the digestive tract as well as provide flavoring and coloring. Generic and branded medicines have the same active ingredients, but the excipients may vary depending on the manufacturing processes of different pharmaceutical companies.

Often, coloring ingredients also differ, helping to distinguish between products. The FDA and other drug regulating companies the world have rigid specifications regarding this. Over are strict about this. The generic drug must have the same strength, purity, identity, and quality as the branded product. 

In the year 2001, there was a coalition of consumer groups that filed a suit against Barr Laboratories and AstraZeneca. The charge said that the companies illegally kept a generic version of an important breast cancer drug off the market. A 1993 agreement between the two companies had cost several breast cancer patients tens of an exorbitant million of dollars. 

The argument against the charge was that the company needed the extra money to continue research to fund the research that results in new drugs. Pharmaceutical industry analyst at Ryan, Beck & Company, Neil B. Sweig, said that the two companies were doing what they felt was necessary to protect their shareholders.

Generic drugs can be sold in the market as long as they have the same strength, the same route of administration contains the same drug compound as an innovator and the same drug dosage. While they may not be perfect, the differences are minor and do not affect clinical outcomes. 

Generic medicines offer a more economical option to otherwise higher-priced alternatives, and when it comes to matters of health and wellbeing, any relief plays a significant role.

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