Shots:
Regulatory momentum accelerated globally with multiple biosimilars securing key approvals and positive opinions, including Sandoz’s Enzeevu (Eylea biosimilar) in the US and Canada, Accord BioPharma’s Filkri (Neupogen biosimilar) US FDA approval, EC approvals for Gotenfia (Simponi biosimilar) and Ranluspec (Lucentis biosimilar), and CHMP positive opinions for tocilizumab and insulin biosimilars.
Strategic partnerships expanded regional access as companies including Alvotech, Bio-Thera Solutions, Formycon,…
Shots:
The US FDA has granted IND clearance to initiate P-I trial of HLX15-SC, a biosimilar version of Darzalex Faspro (daratumumab), for the 1L treatment of multiple myeloma
In Jun 2024, the P-I study of HLX15 (IV; Biosimilar, Darzalex) met its 1EP, demonstrating similar PK & comparable safety & immunogenicity to US, EU, & China-sourced…

