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Takeda
NEWS

Takeda Reports Positive P-III (KEPLER) Results of Entyvio in Pediatric Ulcerative Colitis

Shots: Takeda reported positive data from the global P-III (KEPLER) study evaluating IV ENTYVIO (vedolizumab) in children and adolescents (ages 2–17) with moderate to severe ulcerative colitis (UC) who had inadequate response to conventional therapies and/or TNF antagonists Nearly half (47.3%) of pts achieved the 1EP of clinical remission at Wk. 54, while 34.7% achieved…
February 20, 2026

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NEWS

Alvotech Reveals PK Data on AVT80 (Biosimilar, Entyvio)

Shots: Alvotech reported positive top-line data from the AVT80-GL-P01 PK study comparing AVT80 with Entyvio in healthy adults The study met all 1EP, demonstrating PK similarity between AVT80 & Entyvio following a single 108mg/0.68mL SC dose, supporting AVT80’s biosimilar profile Alvotech is developing AVT16 (IV) & AVT80 (SC) as Entyvio’s biosimilars, with the AVT80-GL-P01 study…
February 5, 2026

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NEWS

Polpharma Biologics Enters into Licensing Deals with MS Pharma for Multiple Biosimilar Candidates

Shots: Polpharma has entered into licensing deals with MS Pharma to commercialize PB016 (vedolizumab), PB018 (ocrelizumab), & PB019 (guselkumab) biosimilars across the Middle East & North Africa (MENA) region As per the deal, MS Pharma will be responsible for registration, marketing, & distribution of the 3 biosimilars in MENA, while Polpharma will handle development, manufacturing,…
September 2, 2025

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NEWS

Polpharma Biologics Collaborates with Fresenius Kabi to Commercialize PB016 (Biosimilar, Entyvio)

Shots: Polpharma has entered into a global licensing agreement with Fresenius Kabi to commercialize PB016, a biosimilar version of Takeda’s Entyvio (vedolizumab) for the treatment of mod. to sev. ulcerative colitis & Crohn’s disease As per the deal, Fresenius will obtain global commercialization rights to PB016, excl. Middle East & North Africa, while Polpharma will…
August 5, 2025

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Viewpoints_Marcelo Freire
VIEWPOINTS

Takeda at UEG Week 2024: Marcelo Freire from Takeda in an Enlightening Conversation with PharmaShots

Shots:  Recently, Takeda shared 32-week interim results from the VERDICT study, which evaluated Entyvio (vedolizumab) for the treatment of patients with ulcerative colitis (UC)  Entyvio achieved a stringent endpoint of disease clearance, a new concept in UC clinical research, which is a combination of clinical, endoscopic, and histologic remission  Today at PharmaShots, we are joined…
December 2, 2024

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NEWS

Alvotech Reports the Initiation of Confirmatory Trial of AVT16 (Biosimilar, Entyvio) 

  Shots:  Alvotech has begun the confirmatory trial of AVT16, biosimilar version of Entyvio (vedolizumab), that targets alpha-4-beta-7 protein for treating Ulcerative Colitis and Crohn’s disease  The P-III (AVT16-GL-C01) trial is a double-blind, two-arm study comparing the efficacy, safety & immunogenicity of AVT16 vs Entyvio in patients of age 18-80yrs. with moderate to severe active…
September 25, 2024

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Viewpoint_Adnrea_Stancati_2020
VIEWPOINTS

PharmaShots Interview: Takeda’s Andrea Stancati Shares Insights on Entyvio (vedolizumab) SC Formulation

In a recent interview with PharmaShots, Andrea Stancati, Vice President, Head GI Global Medical Franchise shares his insights and highlights of Entyvio (vedolizumab) Shots: The ongoing P-IIIb VISIBLE OLE study involves assessing of Entyvio (SC) in adult patients with UC or CD, following enrolment and participation in the VISIBLE 1 (UC) or VISIBLE 2 (CD)…
October 23, 2020

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