FDA — authorised 27 July 2018
- Application: BLA125544
- Marketing authorisation holder: CELLTRION INC
- Indication: Labeling
- Status: approved
🇺🇸 Remicade in United States
FDA authorised Remicade on 27 July 2018
Marketing authorisations
FDA — authorised 6 December 2019
- Application: BLA761086
- Marketing authorisation holder: AMGEN INC
- Status: approved
FDA — authorised 26 December 2023
- Application: BLA761054
- Marketing authorisation holder: SAMSUNG BIOEPIS CO LTD
- Indication: Labeling
- Status: approved
The FDA approved Remicade (infliximab-abda) for marketing in the United States on 26 December 2023. The approval was granted to Samsung Bioepis Co Ltd, the marketing authorisation holder. The indication approved is for the labelling of the product, which is not specified in the available information.
FDA — authorised 22 February 2024
- Application: BLA761358
- Marketing authorisation holder: CELLTRION
- Indication: Manufacturing (CMC)
- Status: approved
The FDA approved CELLTRION's Remicade for manufacturing (CMC) on 2024-02-22. This approval allows CELLTRION to manufacture Remicade in the United States. The application number for this approval is BLA761358.
FDA — authorised 28 February 2025
- Application: BLA103772
- Marketing authorisation holder: CENTOCOR INC
- Indication: Labeling
- Status: approved
The FDA granted marketing authorisation to Remicade, a product of Centocor Inc, on 28 February 2025. This authorisation was based on a standard application pathway. The approved indication for Remicade is listed in its labelling.
Remicade in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Remicade approved in United States?
Yes. FDA authorised it on 27 July 2018; FDA authorised it on 6 December 2019; FDA authorised it on 26 December 2023.
Who is the marketing authorisation holder for Remicade in United States?
CELLTRION INC holds the US marketing authorisation.