
reference drug
A reference drug, also known as a branded or innovator drug, is the original medication developed by a pharmaceutical company after successful clinical trials. It has established quality, safety, and effectiveness and is approved by regulatory authorities. When other manufacturers create generic versions, they must demonstrate their product is equivalent to the reference drug in terms of strength, safety, and efficacy. The reference drug serves as the standard benchmark in comparisons and helps ensure consistency and confidence in similar medications available on the market.