Alvotech Reports US FDA BLA Acceptance for AVT80 (Biosimilar, Entyvio)

Shots: The US FDA has accepted a BLA for AVT80, a proposed interchangeable biosimilar to Entyvio (vedolizumab) PFS & autoinjector for SC administration BLA was backed by analytical, PK & immunogenicity data, showing biosimilarity with the reference product. Plus, under a partnership with Teva, Alvotech is responsible for development & manufacturing of AVT80, while Teva…

ByRidhi Rastogi2 days ago

NEWS

Zydus Partners with Bioeq for US Commercialization of Nufymco (Biosimilar, Lucentis)

Shots: Zydus Lifesciences has entered into a strategic licensing, supply & commercialization agreement with Bioeq for Nufymco (ranibizumab), an interchangeable biosimilar to Lucentis, for the US market, marking an expansion of Zydus’ US biosimilar portfolio Under the agreement, Bioeq will handle development, manufacturing, registration & supply of the finished product while Zydus will lead US…

ByPrince GiriDecember 25, 2025

VIEWPOINTS

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

Alvotech Reports US FDA BLA Acceptance for AVT80 (Biosimilar, Entyvio)

Zydus Partners with Bioeq for US Commercialization of Nufymco (Biosimilar, Lucentis)

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

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