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Polpharma Biologics’ PB016 vedolizumab biosimilar has entered regulatory review with the United States Food and Drug Administration and European Medicines Agency, advancing a potential new competitor to Takeda Pharmaceutical Company’s Entyvio for ulcerative colitis and Crohn’s disease. Representative image.

Pharma & Biotech

PB016 versus Entyvio: Polpharma Biologics joins the emerging vedolizumab biosimilar race

by Pallavi Madhiraju
July 31, 2026
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Polpharma Biologics’ PB016 enters FDA and EMA review, adding a new vedolizumab biosimilar challenge to Takeda’s Entyvio franchise.

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Pharma & Biotech

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Representative image of a clinician reviewing skeletal imaging, illustrating Mirum Pharmaceuticals and Incyte’s zilurgisertib Phase 2 progress in fibrodysplasia ossificans progressiva and the rare disease treatment questions facing regulators.

Pharma & Biotech

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Representative image of biopharma laboratory research. Gilead Sciences and Merck’s latest Phase 3 updates highlight the promise of once-weekly HIV treatment with islatravir and lenacapavir, while raising fresh questions over Trodelvy’s lung cancer expansion strategy.

Pharma & Biotech

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TAGS

clinical trials Eli Lilly and Company European Medicines Agency FDA FDA approval immuno-oncology immunotherapy Inc. Johnson & Johnson medical devices oncology precision oncology rare disease U.S. Food and Drug Administration United States Food and Drug Administration

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