Shots:
- The US FDA and EMA have accepted the BLA & MAA, respectively, for PB016, a biosimilar version of Entyvio (vedolizumab) lyophilized vial for IV administration
- BLA was supported by an extensive development program assessing PB016 vs Entyvio, to evaluate its similarity to the reference product, consistent with regulatory requirements for biosimilar approval
- PB016 is an integrin receptor antagonist for mod. to sev. active ulcerative colitis & Crohn’s disease, developed by Polpharma, with Fresenius Kabi holding exclusive global commercialization rights outside the Middle East & North Africa, pending approvals
Ref: Fresenius Kabi | Image: Fresenius Kabi | Press Release
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