On May 10, 2026, Shanghai Henlius Biotech announced that the FDA has approved its IND for a proposed biosimilar, HLX05-N, to Eli Lilly’s ERBITUX (cetuximab) product for the treatment of metastatic colorectal cancer (mCRC). ERBITUX is approved in the United States for the treatment of KRAS wild-type, epidermal growth factor receptor (EGFR)-expressing mCRC, among other indications.
Henlius indicated that it plans to advance the program through clinical development and pursue a future BLA submission to the FDA. To date, no biosimilars of cetuximab have been approved in the United States or Europe.