FDA Reviews Celltrion's Remicade Biosimilar Today Save

The arthritis advisory committee of the Food and Drug Administration (FDA) is scheduled to meet today, February 9th to review the efficacy and safety of Celltrion's biosimilar form of infliximab (Remicade) that is currently marketed in other countries.

In early negotiations FDA reviewers have indicated the biosimilar "highly similar" to the branded product with regard to safety, purity and potency. The biosimilar product is called Remsima, and is intended to treat rheumatoid arthritis and inflammatory bowel conditions such as Crohn's disease.

Celltrion has partnered with Pfizer (and its biosimilar divison Hospira) to sell Remsima in the United States as a reduced cost version of Remicade, or infliximab, which had global 2014 sales of almost $10 billion.

Remsima would become the second approved biosimilar in the United States, following Novartis Zarzio, a biosimilar version of Amgen's Neulasta antibody, that was approved by the FDA in September 2015.