Tags : Osteoporosis

Biosimilars

EMA’s CHMP Recommends the Approval of Two Biosimilar Referencing Lilly’s

Shots: The CHMP has adopted the positive opinion recommending the approval of Theramex’s  Livogiva (biosimilar, teriparatide) intended for the treatment of osteoporosis and will be available as a solution for injection (20 micrograms/80 microliters) The CHMP has also recommend marketing authorization to EuroGenerics’ Qutavina (biosimilar, teriparatide) to treat osteoporosis, also available as a solution for […]Read More

Biosimilars

Mochida Launches Teriparatide Biosimilar for the Treatment of Osteoporosis in

Shots: Mochida launched “Teriparatide BS subcutaneous injection Kit 600μg MOCHIDA” as it has been listed on the NIH reimbursement price list The launch will improve QoL and lead to the reduction of the financial burden of patients with osteoporosis. The teriparatide biosimilar has developed in collaboration with Gedeon Richter Teriparatide BS Injection Kit 600μg is […]Read More

Regulatory

Amgen and UCB’s Evenity (Romosozumab) Receive CHMP Positive Opinion to

Shots: The EMA’s CHMP has adopted a positive opinion recommending marketing authorization for Evenity (romosozumab) based on P-III global studies including FRAME, ARCH and BRIDGE studies assessing Evenity vs PBO and active comparator in ~11,000 postmenopausal women with osteoporosis at high risk of fracture and with no history of MI or stroke The CHMP’s recommendation […]Read More

Regulatory

Amgen’s Evenity (romosozumab-aqqg) Receives FDA’s Approval for Osteoporosis in Postmenopausal

Shots: The FDA’s approval is based on two P-III FRAME & ARCH studies result assessing Evenity (210mg) vs PBO & alendronate (70mg) in 7,180 & 4,093 postmenopausal women with osteoporosis respectively The P-III FRAME & ARCH study results: @12mos. and 24mos. significant reduction in vertebral (spine) fracture; @33 mos. reduction in risk of clinical fracture; […]Read More