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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,…
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The US FDA grants approval for commercial manufacturing of a biosimilar at Rezon Bio’s Warsaw-Duchnice facility
The FDA approval of the Warsaw-Duchnice facility follows a comprehensive review process and indicates that the site meets regulatory standards for quality systems, technical capabilities, and operational readiness to supply the US market
This approval follows earlier EMA GMP certification and authorization for commercial…

