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

Biosimilar News

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.

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