Celltrion files for US FDA approval of Remsima biosimilar

13 August 2014

South Korean biopharmaceutical firm Celltrion (Kosdaq: 068270) says it has completed the filing procedure to obtain US Food and Drug Administration approval for Remsima, its biosimilar infliximab, the active ingredient of US health care giant Johnson & Johnson’s (NYSE: JNJ) blockbuster anti-inflammatory drug Remicade, which generated global revenues of $8.4 billion last year.

Remsima is expected to be the first biosimilar monoclonal antibody to be filed through the FDA’s biosimilar regulatory approval pathway, the Biologics Price Competition and Innovation Act of 2009 (BPCIA). This marks the first 351(k) biosimilar monoclonal antibody (MAb) application to be filed in the USA and the second application for a biosimilar to be filed through the US BPCIA, said Celltrion.

Follows Sandoz submission for filgrastim biosimilar

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK