Shanghai Henlius Reports the US FDA’s BLA Acceptance for HLX04 (Biosimilar, Avastin)

Shots: The US FDA has accepted the BLA for HLX04, a biosimilar version of Avastin (bevacizumab) BLA was supported by analytical similarity studies, a P-I PK comparability trial in healthy subjects, and a multicenter P-III trial in pts with metastatic colorectal cancer, evaluating HLX04 vs the reference product for safety, PK, and immunogenicity Henlius is advancing a P-II/III trial of HLX04 + serplulimab for 1L…

ByDipanshu DixitJanuary 13, 2026

Advancing Lupus Research: Devon Kelly from Lupus Nexus in a Stimulating Conversation with PharmaShots

Shots: Research into Lupus has yielded groundbreaking results in pharmacokinetics and pharmacodynamics, yet experts still don't understand its cause Lupus Research Alliance (LRA) recently launched a platform called Data Repository, Exchange, and Analytics (DREAM) for data sharing and partnerships for research in lupus Devon Kelly, Director of Lupus Nexus at the Lupus Research Alliance, sheds…

BySaurabh ChaubeyMay 19, 2025

Stephen Pagnotta Shares Insights on the US FDA Approval of the Cyltezo Pen, a New Autoinjector Option for Cyltezo

Shots: Stephen gave a brief introduction about Cyltezo (an FDA-approved interchangeable Humira biosimilar) and spoke about the features of the Cyltezo Pen (a new autoinjector) approved by the US FDA He also gave a comparative view of the Cyltezo Pen vs. the conventional Cyltezo PFS. He also talked about how BI is informing and educating…

BySenior EditorSeptember 5, 2023

Shanghai Henlius Reports the US FDA’s BLA Acceptance for HLX04 (Biosimilar, Avastin)

Advancing Lupus Research: Devon Kelly from Lupus Nexus in a Stimulating Conversation with PharmaShots

Stephen Pagnotta Shares Insights on the US FDA Approval of the Cyltezo Pen, a New Autoinjector Option for Cyltezo

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