Blog Big Molecule Watch February 09, 2016

FDA Scientists Express View that Celltrion’s Infliximab Biosimilar is “Highly Similar” to Remicade, Meet Today to Discuss Application

Following FDA support announced last Friday for Celltrion’s proposed Remicade® biosimilar (“CT-P13”), the FDA is holding an Advisory Committee meeting today to discuss Celltrion’s application. On Friday, the FDA said that based on its review of the data, Celltrion’s CT-P13 has been demonstrated to be highly similar to Remicade, notwithstanding minor differences in clinically-inactive components. The FDA has released a series of four questions that it intends to pose at the meeting today, which will culminate in a vote as to whether CT-P13 should receive licensure.

Relatedly, later today Janssen and Celltrion will appear before the District Court judge for a status conference.

Stay tuned to the Big Molecule Watch for updates on the Advisory Committee meeting and status conference in Janssen v. Celltrion.