Innovator
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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