Fresenius Kabi Reports FDA and EMA Acceptance of PB016 (Biosimilar, Entyvio) for Review

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…

ByRidhi RastogiAugust 3, 2026

NEWS

Alvotech Reports US FDA BLA Acceptance of AVT16 (Biosimilar, Entyvio)

Shots: The US FDA has accepted BLA for AVT16, a biosimilar to Entyvio (vedolizumab) as a lyophilized vial for IV administration, to treat adults with mod. to sev. active ulcerative colitis & Crohn’s disease BLA is supported by analytical, PK, & immunogenicity data demonstrating biosimilarity between AVT16 & the reference product, plus Alvotech has filed a…

ByRidhi RastogiJune 8, 2026

NEWS

Samsung Bioepis Partners with Sandoz for Up to Five Biosimilar Candidates

Shots: Samsung Bioepis has entered into a global license, development & commercialization agreement with Sandoz for up to five biosimilars, incl. SB36 (preclinical), a biosimilar version of Entyvio (vedolizumab) Samsung Bioepis will handle development, manufacturing & regulatory filings, while Sandoz will lead commercialization globally (excl. China, Hong Kong, Taiwan, Macau & Republic of Korea) The…

ByRidhi RastogiMarch 18, 2026

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…

ByPrince GiriFebruary 20, 2026

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…

ByRidhi RastogiFebruary 5, 2026

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,…

ByRidhi RastogiSeptember 2, 2025

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…

ByRidhi RastogiAugust 5, 2025

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…

BySaurabh ChaubeyDecember 2, 2024

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…

ByDipanshu DixitSeptember 25, 2024

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)…

BySenior EditorOctober 23, 2020

Fresenius Kabi Reports FDA and EMA Acceptance of PB016 (Biosimilar, Entyvio) for Review

Alvotech Reports US FDA BLA Acceptance of AVT16 (Biosimilar, Entyvio)

Samsung Bioepis Partners with Sandoz for Up to Five Biosimilar Candidates

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

Alvotech Reveals PK Data on AVT80 (Biosimilar, Entyvio)

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

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

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

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

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

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