Innovator, Generic Drug and Reference Standard | A Comprehensive Review


An innovator in the context of drugs refers to the original developer or manufacturer of a new pharmaceutical product.

 - Example: Astellas is the innovator of Veozah, as they researched, developed, and brought the drug to market first.

Generic Drug

Generic drugs are generic versions of a pharmaceutical product that are approved as equivalent to the original innovator drug.

 - Example: Once Astellas patent for Veozah expires, other companies can produce generic versions, known as generic drugs, using the same active ingredients.

Reference Standard

 A reference standard is a known and well-characterized substance used as a reference in testing and comparing the quality of other substances.

 - Example: The United States Pharmacopeia (USP) sets reference standards for various drugs to ensure consistency and quality. These standards help manufacturers and regulators ensure that a drug, whether innovator or generic, meets specified criteria.

In short, an innovator develops the original drug, a Lister drug is a generic equivalent, and a reference standard is a benchmark used to ensure the quality and consistency of pharmaceutical products.

Read also: Difference Between 505 (b1) and 505 (b2)

Resource person: Amit Singh

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