Generic Medicines and Biosimilars

OCTOBER 30, 2021


A generic medicine is a pharmaceutical drug that contains the same chemical substance as its brand-name counterpart but it may differ in some characteristics such as manufacturing process, formulations, excipients, color, taste, and packaging. They are usually subject to government regulation in the countries in which they are used and have to go through all the quality checking processes. A generic medicine is sold for a significantly lower price than its branded equivalent. They may be 80-85 % cheaper than the original drug.

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When a company brings a new drug to the market, it has spent a substantial amount of money on research, development, marketing, and promotion of a drug. A patent is granted by the drug regulating authority of that country that gives the company an exclusive right to sell the drug as long as the patent is in effect. Most countries’ patents give 20 years of protection which can be extended a few years more if certain goals are carried out. As the patent is near to expire, other manufacturers can apply to the medicine regulating authority to grant permission to make and sell a generic version of the drug.

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A generic medicine is cheaper as the manufacturer has not spent on developing and marketing a new drug. Their cost of production is low. When multiple manufacturers begin producing and selling the drug, the competition among them drives the price down even further. Brand names (trade or proprietary names) are usually capitalized while generic names (nonproprietary names) are written in a small cases.

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Following are some examples of branded medicines and their generic equivalent :

Generic NamesBrand Names
atenololTenormine
captoprilCapoten
diazepamValium
doxazocinCardura
lorazepamAtivan
frusemideLasix
propranalolInderal
diclofenacVoltran
alprazolamXanax
carbamezipineTegretol

Biosimilar

A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorized original product (reference medicinal product). A biosimilar demonstrates the similarity to the reference product in terms of quality, characteristics, biological activity, safety, and efficacy based on a comprehensive compatibility exercise.

Unlike generic medicine, a biosimilar is not a copy of the original product. They are similar but not an exact replica of the original product. The manufacturing of biologics and biosimilar is very complex with many steps being involved. Slight variation in the manufacturing process can create a final product that is not exactly identical. Every step from selection of host cell, purification, protein sequencing, and post-translational modification may change the structure of the biosimilar relative to the original biologic.

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After the first approval of recombinant insulin in 1982, the number of biological drugs has shown a continued increasing trend. Biologics are, for example, hormones, vaccines, cytokines, clotting factors, genes, and cell therapies. The comparison of biosimilar and the reference product is more complex than that required for generic medicines. Biosimilar cost is much lesser than the original reference medicine. The manufacturing process of biologics and biosimilar is so complex that no two versions are identical. In 2017 FDA decided on a different approach to naming the biologics to avoid confusion. It proposed that all biological products and biosimilars receive unique nonproprietary names. Each product gets a “core” name followed by a unique but meaningless four letters suffix. So every biosimilar on the market has a name that is both related to the original product but is also unique. For example, a biosimilar of filgrastim with a four-letter suffix is filgrastim-sndz.

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