CHMP is positive on two generic Taxoteres
This article was originally published in Scrip
The European Medicine Agency's scientific committee, the CHMP has this month issued positive opinions on four new generic medicines, including two versions of Sanofi's anticancer Taxotere (docetaxel).
The committee recommended the approval of both Accord's Docetaxel Accord and Fresenius Kabi Oncology's Docetaxel Kabi for treating breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma and head and neck cancer. Taxotere was approved back in 1995 and has recently been hit hard by generic erosion. Sanofi's 2011 third quarter net sales were down by 65% compared with the previous third quarter to reach €186 million.
The CHMP also recommended a green light for Teva's own versions of two Novartis bone drugs. Zoledronic Acid Teva, a generic of Zometa, is intended for preventing skeletal related events in adults with advanced malignancies involving bone and for treating adults with tumour-induced hypercalcaemia. Zoledronic Acid Teva Pharma, a generic of Alcasta, is a solution for infusion for treating: osteoporosis in post-menopausal women and in men at increased risk of fracture; osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and in men at increased risk of fracture; and Paget’s disease of the bone in adults.