Agency Considers Generic Biotech Approval Process

Published Online: Monday, March 1, 2004

The FDA is looking at the approval process for generic versions of biotechnologically produced drugs. It is assessing whether these drugs should be allowed to hit the market without extensive clinical testing once the patent of the original drug has lapsed. When generic manufacturers of normal synthetic medicines seek approval, the process is rather straightforward. The reason is that the active-ingredient molecule and the production process are relatively simple. Therefore, it is easier to guarantee that the compound in the gneric preparation matches the original.

The same cannot be said about the synthesis of genetically modified proteins. Subtle variations in the process could lead to noticeable differences in the products. If such is the case, each manufacturer might have to develop and test an entirely new process. This is a concern for generic- company officials because they claim that they do not have the financial resources to conduct the process. Until a final decision is reached, the FDA will evaluate each case on its own merit.

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