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Entyvio

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Fresenius Kabi’s PB016 vedolizumab biosimilar has entered FDA and EMA review, advancing a potential Entyvio competitor for ulcerative colitis and Crohn’s disease. Representative image.
Pharma & Biotech

What Fresenius Kabi’s PB016 regulatory filings mean for the Entyvio biosimilar market

Fresenius advances PB016 into FDA and EMA review, but competition, manufacturing scrutiny and IV-only positioning will shape its launch path.

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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

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

Entyvio pediatric filing puts Takeda at the centre of the next IBD treatment debate

Find out how Takeda’s pediatric Entyvio review could change biologic treatment choices in ulcerative colitis and Crohn’s disease.

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Samsung Bioepis and Sandoz expand biosimilar deal to cover vedolizumab and four early-stage candidates
Pharma & Biotech

Early-stage biosimilar deal between Samsung Bioepis and Sandoz covers vedolizumab and four undisclosed molecules

Samsung Bioepis and Sandoz expand their biosimilar partnership to cover vedolizumab SB36 and four early-stage candidates. What this means for the IBD biologics market.

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