Aprogen/Nichi-Iko's Remicade Biosimilar Clears Japan’s Approval Review
Executive Summary
South Korea's Aprogen, which has teamed up with Japan's Nichi-Iko, is set to receive an official regulatory approval for its biosimilar infliximab in Japan and launch the product possibly this year, becoming the second Remicade biosimilar to be marketed in the country after Celltrion's Remsima.
You may also be interested in...
Policy Prescriptions: Kite's CAR-T; Price And Value Scrutiny; Biosimilars; Manufacturing Missteps
Kite's CAR-T application seems to be sailing ahead without US FDA AdComm review; large employers in the US look into value-based contracting while European regulators band together on joint price negotiations; Teva is back at FDA with its EpiPen application. Policy Prescriptions rounds up recent regulatory news and trends reported by sister publication the Pink Sheet.
Policy Prescriptions: Kite's CAR-T; Price And Value Scrutiny; Biosimilars; Manufacturing Missteps
Kite's CAR-T application seems to be sailing ahead without US FDA AdComm review; large employers in the US look into value-based contracting while European regulators band together on joint price negotiations; Teva is back at FDA with its EpiPen application. Policy Prescriptions rounds up recent regulatory news and trends reported by sister publication the Pink Sheet.
Nichi-Iko Buys Sagent To Strengthen US Biosimilars Presence
Nichi-Iko Pharmaceutical Co. Ltd. will pay $736m in cash for Sagent Pharmaceuticals Inc. in a deal that will further expand the Japanese company's biosimilars business beyond Asia and diversify the US generics firm's injectable medicines portfolio.