Tags : CT-P10’s (rituximab

Biosimilars Regulatory

Celltrion and Teva Announces Approval Recommendations for CT-P10’s (rituximab, biosimilar)

Shots: FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 16-0 in favor of CT-P10 and recommended it on the basis of analytical biosimilarity, nonclinical & clinical pharmacology, immunogenicity, efficacy and safety data with no difference in safety, purity, and potency b/w CT-P10 and Rituxan Teva to acquire commercialization rights for CT-P10 post-FDA approval in three indications […]Read More