FDA Receives First Biosimilar Application for a Monoclonal Antibody

  • This page as PDF


On August 11, Celltrion announced the completion of their 351(k) filing procedure to FDA on Aug. 8, for its Remicade (infliximab) biosimilar product, Remsima (infliximab).
Please note: This is an archived post. Some of the information and data discussed in this article may be out of date. It is preserved here for historical reference but should not be used as the basis for business decisions. Please see our main Insights section for more recent posts.

Celltrion’s filing is the first submission for a monoclonal antibody (mAb) biosimilar product and the second biosimilar application filing to the Agency. On July 24, Sandoz became the first company to announce that FDA accepted its application for review of the company’s filgrastim biosimilar product.

Celltrion’s Remsima is already approved for use in over 50 countries globally, including multiple highly regulated markets such as Europe, Canada, and Japan. Celltrion completed additional clinical trials for their U.S. application after consultation with FDA in order to confirm Remsima bioequivalence to the brand product Remicade. The bioequivalency data combined with Celltrion’s global clinical trial data were provided in the 351(k) submission to the Agency. Celltrion’s marketing timeline for Remsima in the U.S. is dependent on a currently filed lawsuit in the District Court of Massachusetts seeking a declaratory judgment that Janssen’s remaining patents on the infliximab branded product, Remicade, are invalid and/or unenforceable (these patents run through 2018 in the U.S.).

Celltrion anticipates FDA licensure for Remsima within one year but the timeline for marketing Remsima in the U.S. will likely be dependent upon the outcome of the lawsuit filed against Janssen. Celltrion did not publically announce which Remicade indications the company requested in its application to the Agency. However, it is likely that, similar to Sandoz, Celltrion is seeking multiple U.S. indications and relying on extrapolation of clinical data from one condition to support licensure of biosimilarity in other conditions. In the U.S. Remicade is approved for ankylosing spondylitis, rheumatoid arthritis, Crohn’s disease (including pediatrics), ulcerative colitis (including pediatrics), psoriasis and psoriatic arthritis.

FDA has ten months to review a biosimilar application from the date it is submitted (albeit only a 70 percent performance goal under the user fees for biosimilars). Irrespective of when FDA approves Remsima, the Massachusetts court will likely impact the Celltrion decision to launch Remsima in the U.S.

View Celtrion’s announcement.

View Sandoz July announcement.

Webinar | Election 2024: What’s at Stake for Healthcare? 

On August 14 at 1:30 PM ET, Avalere experts and guests will discuss the 2024 elections, exploring the candidates’ health policy approaches and implications for stakeholders. 

Learn More

From beginning to end, our team synergy
produces measurable results. Let's work together.

Sign up to receive more insights about Regulatory Strategy and FDA Policy
Please enter your email address to be notified when new Regulatory Strategy and FDA Policy insights are published.

Back To Top