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Polpharma Biologics gains FDA and EMA review acceptances
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Fusion42 · 3 August 2026 · Fusion42 review
Polpharma Biologics has received FDA and EMA acceptance for review of its PB016 vedolizumab biosimilar applications, marking a significant step in making affordable biologic treatments available for ulcerative colitis and Crohn's disease.
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◆ ◆ The Wire takeaway
You have a new route to enter the inflammatory bowel disease treatment market as regulatory gateways open for affordable biosimilar vedolizumab. This clearance shifts competition by lowering barriers to biologic therapy provision.
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