BIOSIMILARS UPDATES

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...

07 OCT 2023 | Samsung Bioepis Presents Switching Study Results for SB15, Biosimilar to Regeneron’s Eylea® (aflibercept) Samsung Bioepis announced its Phase III switching study results for SB15, biosimilar to Regeneron’s Eylea® (aflibercept), at...

02 OCT 2023 | Nobel Prize Awarded to Katalin Karikó and Drew Weissman for Their Work Which Supported the mRNA COVID-19 Vaccine The Nobel Assembly at Karolinska Institutet awarded the 2023 Nobel Prize in Physiology or Medicine jointly to Katalin...

22 SEP 2023 | KR | Prestige Biologics Partners with Dr. Reddy’s Laboratories Subsidiary in Strategic Manufacturing Collaboration Prestige Biologics, a contract development and manufacturing organization (CDMO), announced it has signed a...

15 SEP 2023 | US | Novartis Shareholders Approve Sandoz Spin-Off On 15 September 2023, Novartis shareholders approved the proposed Sandoz spin-off, Novartis’ generics and biosimilars business at its Extraordinary General Meeting.   The proposed...

08 SEP 2023 | Coherus Completes Acquisition Of Surface Oncology Coherus Biosciences announced that it completed its acquisition of Surface Oncology, Inc., a clinical-stage immuno-oncology company.  Coherus’ pipeline now has a number of new...

01 SEP 2023 | AU | Celltrion Submits Marketing Application For CT-P43, Biosimilar To Janssen’s Stelara® (Ustekinumab) Business Korea reported that Celltrion filed an application with Australia’s Therapeutic Goods Administration (TGA) for...