US FDA starts to assess Celltrion’s Herzuma approval

Celltrion will resume the U.S. approval acquisition process as completing submission of additional documents to the FDA for ‘Herzuma,’ an antibody biosimilar for breast cancer.

Celltrion announced the company officially submitted additional revision documents for product approval of Herzuma(CT-P6) from the U.S. FDA. Once these documents are submitted, the FDA normally completes the approval as...