Question

Explain why a generic drug product can be a pharmaceutical equivalent but not identical to the brand drug product?

Answer 1

Generic drugs are copies of brand name drugs and are the same as those brand name drugs in dosage from, safety, strength, route of administration, quality, performance characteristics and intended use. The generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs by this way generic drugs are pharmaceutically Equalant to brand name drugs.

But generic drug products are not identical to the brand name drugs in terms of

- generic drug products are typically sold at substantial diacounts from their brand name counterparts

- generic drug product development uses a different approach and strategy compared to that used to develop a brand name drug product

- generic drugs are allowed for sale only after the patent on the original drug expire

- generic drug product has the same active pharmaceutical ingredient as the original. But it may differ in some characteristics such as manufacturing process, formulation, Excipient, colour, taste and packing