Shots:
May 2026 saw strong biosimilar momentum with key approvals including Bevqolva (Health Canada), Langlara and Immgolis/Immgolis Intri (US FDA), Bysumlog and Dazparda (EC), and Eyzanfy (MFDS), expanding competition across oncology, diabetes, immunology, and ophthalmology.
Strategic progress continued with Henlius’ FDA IND clearance for HLX05-N, alongside partnerships between IQVIA–Kexing Biopharm and Polpharma–Tuteur, supporting global development and commercialization efforts.
Commercialization accelerated through the EU launches of FYB203 and Opuviz, as well as Samsung Bioepis’ ustekinumab biosimilar launch in Japan,…
Shots:
The US FDA has granted IND clearance to HLX05-N, a biosimilar version of Erbitux (cetuximab) for the treatment of metastatic colorectal cancer (mCRC)
HLX05-N is developed by Henlius in accordance with biosimilar guidelines in China, the EU, & the US, and showed high similarity to reference cetuximab in analytical & non-clinical comparative studies
Cetuximab…
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The NMPA has granted IND clearance to Henlius’ HLX05-N, a biosimilar version of Erbitux (cetuximab), for the treatment of metastatic colorectal cancer (mCRC)
HLX05-N showed high similarity to reference cetuximab in analytical & non-clinical studies, with Henlius planning to initiate an international multi-center P-I trial upon meeting required conditions
Cetuximab is an anti-EGFR monoclonal…

