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 Rastogi2 days ago

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

TOP 20

Top 20 Monoclonal Antibodies of 2025

Shots: Redefining treatment paradigms, monoclonal antibody therapies utilize advanced mechanisms of action to provide care across multiple therapeutic areas As of 2024, the global monoclonal antibody therapy market was valued at $252.6B and is projected to reach $497.5B by 2029, growing at a CAGR of 14.5%. Keytruda leads the market with $29.48B in revenue, followed…

ByPrince GiriSeptember 18, 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

TOP 20

Top 20 Biopharma Companies of 2025

Shots: Driven by innovation and a steadfast commitment to advancing cutting-edge therapies, the biopharma industry experienced robust growth in 2024, marked by significant revenue milestones With a projected compound annual growth rate (CAGR) of 12.87%, the global biopharma market is expected to reach $1.41 trillion by 2032. In 2024, Pfizer led the industry with total…

ByPrince GiriApril 24, 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

INSIGHTS+

Top Performing Drug – Entyvio (February Edition)

Shots: In continuation of our previous series on the Top-Performing Drug of the month, based on 2021 revenue, this month we have selected Entyvio and prepared a curated analysis report for our readers Entyvio works on the mechanism of an integrin receptor antagonist, which is approved for moderate to severe active ulcerative colitis and active…

BySenior EditorFebruary 22, 2024

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)

Top 20 Monoclonal Antibodies of 2025

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

Top 20 Biopharma Companies of 2025

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)

Top Performing Drug – Entyvio (February Edition)

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