On 14 July 2026, Merck KGaA announced that Erbitux® (cetuximab) was approved by the European Commission for adults with BRAF V600E mutant metastatic colorectal cancer (mCRC) in combination with Pierre Fabre’s Braftovi® (encorafenib) and FOLFOX (fluorouracil, leucovori, and oxaliplatin) for first line treatment and in combination with Braftovi® in patients who have received prior systemic therapy. The EC approval follows the CHMP’s positive opinion in May 2026.
Matthias Wernicke, Merck’s Head of Global Therapeutic Area Specialty Care stated this approval “marks an important milestone for patients … as BRAF V600E mutant mCRC is associated with a historically poor prognosis and limited effective options.” The Erbitux®/Braftovi®/FOLFOX combination received accelerated approval by the FDA in December 2024 and traditional approval in February 2026 for the same indication.
Merck KGaA licensed the right to market Erbitux® outside the US and Canada from ImClone LLC, a wholly-owned subsidiary of Eli Lilly, in 1998.
No cetuximab biosimilars have been launched to date in China, the United States, Europe or Japan. Alkem’s Cetuxa™ was reportedly the first cetuximab biosimilar to be approved and launched in India (January 2023 and May 2023, respectively). Alkem’s biological arm, Enzene, entered into a strategic collaboration with Lupin in May 2023 for Indian commercialisation of Cetuxa™. In February 2026, R-Pharm’s Arcetux™ (cetuximab) was the first biosimilar cetuximab to gain approval in Russia. On 8 July 2026, Shanghai Henlius Biotech announced that the first patient in China had been dosed in a multicentre Phase 1 clinical trial of its cetuximab biosimilar, HLX05-N.