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 approved Immgolis & Immgolis Intri, the interchangeable biosimilar versions of Simponi & Simponi Aria (golimumab), respectively
Immgolis & Immgolis Intri are both approved for the treatment of adults with mod. to sev. active rheumatoid arthritis in combination with methotrexate, while Immgolis is additionally approved for mod. to sev. active ulcerative…

