FDA Postpones Hearing for Remicade Biosimilar
FDA announced that it would postpone a meeting that would be critical for the advancement of Celltrion’s Remicade biosimilar in the US.
FDA announced on Feb. 26, 2015 that it would postpone an advisory committee meeting that would evaluate Celltrion and Hospira’s Remicade (infliximab) biosimilar, Remsima. According to Reuters, FDA said in a statement that the hearing was postponed “due to information requests pending with the sponsor of the application.” Reuters also reported that Citigroup analyst Andrew Baum said the delay appeared procedural, and did not seem to be caused by issues related to the biosimilar, considering that the drug had already been approved in other markets, including Europe.
On Feb. 19, 2015, Celltrion announced that it found that Remsima could save France, Italy, and the UK up to $380 million, stressing the advantages of introducing the biosimilar into various markets. On Feb. 24, 2015 EMA announced that Remsima was launched in a dozen European countries, having been previously approved in September 2013. FDA announced that another meeting would be planned in the future.
Source: Reuters
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
