In May 2018, the European Commission authorized the biosimilar for sale in the European Union (EU). Germany will be the first European market where the drug will be available for all indications of the reference product: rheumatoid arthritis (RA), adult Crohn disease, pediatric Crohn disease, adult ulcerative colitis, pediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

The approval was based on a review of the data that demonstrated the infliximab biosimilar was equivalent to the reference product in terms of both safety and efficacy. The data included a phase 3 confirmatory study in RA that met its primary endpoint of achieving the American College of Rheumatology’s criteria for a 20% improvement (ACR20) response at week 14.

Reference infliximab, sold as Remicade and developed by Johnson & Johnson (J&J), earned an estimated $6.3 billion globally in 2017. However, increased competition from biosimilars is starting to eat away at its market share. During an investor call earlier this year that discussed fourth quarter sales from 2017, it was announced that Remicade sales fell by 9.7% worldwide.

In the United States, Remicade faces biosimilar competition from 2 products: Celltrion and Pfizer’s Inflectra, and Samsung Bioepis and Merck’s Renflexis. In the European Unoin, J&J’s reference infliximab fights for market share from the same products, though Renflexis is marketed under the brand name Flixabi, and Inflectra is marketed under 2 names: Inflectra and Remsima.