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The Generic Pharmaceutical Approval Process

A generic pharmaceutical company, seeking to market an equivalent to a brand pharmaceutical company’s drug product uses the Abbreviated New Drug Application (ANDA) process of the Food and Drug Administration (FDA).

Because the brand drug has been used by millions of consumers for a number of years, the safety and effectiveness of the product is already established. From a public policy standpoint confirming the safety and effectiveness of the generic version of the drug is not necessary. Instead, the generic manufacturer relies on the safety and efficacy data supplied by the brand company in order to avoid duplicating needless clinical testing. However, the generic manufacturer must establish that its product is equivalent to the branded product.

To be approved, a generic must have the same active ingredients, same dosage form, same standards for purity and quality, same standards for manufacturing, same amount of drug absorbed over the same time, and same clinical effect as the brand product.

The generic manufacturer must conduct bioavailability and/or bioequivalence studies of its version of the branded drug to prove that it is the same as the brand drug.

Bioavailability studies assess the rate and extent of absorption and levels of concentration of a drug in the blood stream needed to produce a therapeutic effect. Bioequivalence studies compare the bioavailability of one drug product with another, in this case the innovator's product. When bioequivalence is established, it indicates that the rate of absorption and the levels of concentration of a generic product are substantially equivalent to the branded product. This is the same type of studies brand firms use to support changes to their product, including formulation and strength modifications.

Therapeutic equivalence is a term of art used to describe the sameness of a brand and generic product. Therapeutic equivalence ensures that the manufacturer of the generic product can reliably produce the generic product to predetermined specifications, the same specifications as required by the FDA of the brand company. Once a product has been determined to be therapeutically equivalent, the FDA provides the assurance that the clinical effect and safety profile should be the same as that of the brand product. In order to receive a rating of therapeutic equivalence, the FDA reviews the manufacturer's entire Abbreviated New Drug Application (ANDA) including on-site inspection of the manufacturer's facilities (pre-approval inspection).

The FDA also requires that a company's manufacturing methods conform to current good manufacturing practices (cGMP), as defined in the U.S. Code of Federal Regulations. The generic pharmaceutical company must follow the cGMPs in all phases of the manufacturing process, and must continually monitor compliance and measure quality control. FDA assures that the same quality, purity and manufacturing standards are used across the entire prescription drug sector.

All pharmaceutical products, whether brand or generic, vary slightly. However, the same testing that assures batch to batch consistency for a brand product is used to ensure equivalence of generics.