Remicade loss of exclusivity?

Short answer: there isn’t a single “loss of exclusivity” date for Remicade. For biologics like infliximab (Remicade), protection comes from two separate things: data/market exclusivity and patents. When those protections lapse, biosimilars can compete, but the timing can vary by country.

Key points:
- Data exclusivity in the U.S.: infliximab had 12 years of data exclusivity (from FDA approval in 1998), which would have blocked reliance on the original data. That period ended around 2010, but biosimilar entry was delayed by patents and other protections.
- Real-world competition began later: the first infliximab biosimilar was approved in the U.S. around 2016 (Inflectra/ infliximab-dyyb). Other infliximab biosimilars followed (Renflexis/infliximab-abda; Ixifi/infliximab-qbtx; Avsola/infliximab-axxp) between 2017 and 2019.
- In Europe and other regions, biosimilar entry occurred earlier or later depending on local patent terms and regulatory decisions.
- Result: Remicade is no longer free from competition in many markets, but there wasn’t a single year “Remicade lost exclusivity.” The effect comes from a combination of data exclusivity expiry and patents plus the later entry of biosimilars.

If you want, tell me the country or region and I can give a precise timeline of when Remicade lost exclusivity there and which infliximab biosimilars are available.