FDA panel recommends approval of Celltrion biosimilar

An advisory committee at the US Food and Drug Administration (FDA) has said that pharmaceutical company Celltrion’s proposed biosimilar used to treat Crohn’s disease and rheumatoid arthritis should be approved for sale.

The FDA’s Arthritis Advisory Committee recommended approval by 21 votes to 3 yesterday, February 9.

If approved by the full FDA, it will be the first biosimilar monoclonal antibody drug to be granted marketing rights in the US, the company said.

The drug is a biosimilar of Janssen Biotech’s Remicade (infliximab).

Welcoming the news, Hyoung Ki Kim, Celltrion’s chief executive, said that the committee’s response was an “essential step” in increasing the acceptance of biosimilars.

He added: “We have experienced the benefits of biosimilars outside of the US, including Europe, and are looking forward to advancing our development programme with the FDA.”

A decision from the full FDA is expected in April.