Infliximab regulatory update

EMA's CHMP issued a positive opinion recommending approval of duplicate MAAs from Celltrion and partner Hospira for Inflectra/Remsima infliximab (CT-P13), a biosimilar of Remicade infliximab. Hospira plans to launch the biosimilar as Inflectra in Eastern and Central Europe by year end and said prices for the biosimilar have not been determined. Celltrion - which will market the product as Remsima in the EU - could not be reached for details. Celltrion already markets Remsima in South Korea.

Hospira has co-exclusive rights from Celltrion to commercialize the biosimilar in the U.S., Canada, EU, Australia and New Zealand. Celltrion is partnered with Nippon Kayaku for the biosimilar in Japan. ...