BIOSIMILARS UPDATES

01 DEC 2023 | US | Celltrion Files BLA for Interchangeable Prolia® (Denosumab) Biosimilar with the FDA The Korea Biomedical Review reported that Celltrion has submitted an application for marketing authorisation to the FDA for CT-P41, its...

24 NOV 2023 | Celltrion Applies For EU Approval of CT-P43, Biosimilar to Regeneron’s Eylea® (aflibercept) Celltrion revealed in a corporate filing with the Repository of Korea’s Corporate Filings (DART) that it has applied for marketing...

16 NOV 2023 | US | Approval Alert: AZ’s Truqap® (capivasertib) plus Faslodex® FDA Approved to Treat Advanced HR-positive Breast Cancer AstraZeneca (AZ) announced the FDA approved its Truqap® (capivasertib) in combination with Faslodex...

10 NOV 2023 | EU | CHMP Positive Opinion for 8mg Eylea® (Aflibercept) Bayer announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of 8mg Eylea® (aflibercept) intravitreal injection for the...

01 NOV 2023 | EU | Fresenius Kabi’s Launches First EU Tocilizumab Biosimilar Fresenius Kabi announced it has launched Tyenne®, the first EC-approved biosimilar to Roche’s Actemra®/RoActemra® in the EU.  Tyenne® was approved by the EC on 19...

27 OCT 2023 | US | Sanofi to Spin-Off Consumer Business and Focus on Biopharma by End Q4 2023 Sanofi announced that it will separate its Consumer Healthcare Business as soon as the end of Q4 2024, creating a publicly listed company headquartered...

23 OCT 2023 | US | Approval Alert: FDA Approves Celltrion’s Zymfentra® (infliximab-dyyb), Biosimilar to Janssen’s Remicade®, and the First Approved SC Infliximab Celltrion announced that the FDA has approved its subcutaneous formulation of...

15 OCT 2023 | Samsung Bioepis Reveals SB16 (denosumab) Study Results at ASBMR Samsung Bioepis presented new data on its SB16 (denosumab, biosimilar to Amgen’s Prolia®) at the American Society for Bone and Mineral Research (ASBMR) 2023 Annual...