FDA seeks more data on Teva BLA for biosimilar neutropenia drug
This article was originally published in Scrip
Teva Pharmaceutical Industries' biologics licence application (BLA) for its b granulocyte colony-stimulating factor, to prevent neutropenia, has been knocked back by the FDA which has issued the company a "complete response letter". And with the contents of the letter being kept confidential it is still difficult to judge what the FDA is thinking about when it comes to biosimilar products. Teva did say, however, that while the agency has requested "several items" which it is reviewing, it is not requiring additional pre-marketing clinical trials to complete the review of the application.
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