Agency Considers Generic Biotech Approval Process

The FDA is looking at the approval process forgeneric versions of biotechnologically produceddrugs. It is assessing whether these drugs shouldbe allowed to hit the market without extensiveclinical testing once the patent of the originaldrug has lapsed. When generic manufacturers ofnormal synthetic medicines seek approval, theprocess is rather straightforward. The reason isthat the active-ingredient molecule and the productionprocess are relatively simple. Therefore,it is easier to guarantee that the compound inthe gneric preparation matches the original.

The same cannot be said about the synthesisof genetically modified proteins. Subtle variationsin the process could lead to noticeable differencesin the products. If such is the case, eachmanufacturer might have to develop and test anentirely new process. This is a concern for generic-company officials because they claim thatthey do not have the financial resources to conductthe process. Until a final decision isreached, the FDA will evaluate each case on itsown merit.