At first glance, one might think that copying an innovator drug to produce a generic drug would be pretty simple. Most of the development work has already been done, and the generics producer only has to copy that information and receive approval for an Abbreviated New Drug Application (ANDA) from the FDA. That simple assessment is incorrect for a number of reasons. Generic drugs must work the same and provide the same clinical benefit as the brand-name version, but that does not mean they are identical. Any drug product (a term used for the final form of a drug placed on the market) is a combination of drug substance (the active ingredient), excipients (the non-active ingredients in the tablet, capsule, or vial), the container and its closure system (including how many doses are in the container), and the labeling and prescribing information. The information about the innovator drug will be limited to what’s available on the label and insert, which is only the starting point. A generic drug may contain the chemically same drug substance sourced from the same or a different manufacturer and may contain different excipients. The process of developing a generic drug requires development, verification and validation of the manufacturing process in much the same way as an innovator drug. While drug safety and efficacy trials are not required for an ANDA, the generics manufacturer will still have to demonstrate bioequivalence with the innovator drug in the application, Bioequivalence means that a given generic dose results in a similar patient exposure (in terms of concentration and time) as the innovator drug (for more details about bioequivalence studies for FDA see this link and for EMA see this link). Since generic drugs are competing in the market primarily on price, the cost of their development and manufacturing must be weighed against what the forecast value of the finished product will be on the market (what insurance companies would be willing to pay for a substitute for the innovator drug). The development and regulatory process work to ensure that quality requirements are met before a new generic drug is placed on the market. Read more about generic drugs at the FDA’s Generic Drugs page.

Text Copyright © 2019 Katrina Rogers