On 10 May 2026, Shanghai Henlius Biotech announced that the FDA has approved an Investigational New Drug (IND) application for a Phase 1 clinical trial of HLX05-N, biosimilar to Eli Lilly/Merck KGaA’s Erbitux® (cetuximab), for the treatment of metastatic colorectal cancer (mCRC).
This follows approval of Henlius’ IND application for HLX05-N by China’s National Medical Products Administration in April 2026 for the same indication.
Cetuximab biosimilars have been approved and launched in India (Alkem’s Cetuxa™ approved January 2023, launched May 2023), China (Simcere Zaiming/Mabpharm’s Enlituo® (cetuximab beta) approved June 2024) and Russia (R-Pharm’s Arcetux™ approved February 2026).