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NEWS

Novo Nordisk and Vivtex Partner in ~2.1B Metabolic Deal to Develop Oral Therapies

Shots: Novo Nordisk has partnered with Vivtex to develop next-generation oral biologics for obesity, diabetes, & related comorbidities, leveraging Vivtex’s GI screening & formulation platform Vivtex will license select oral drug-delivery techs to Novo, which will lead global development, regulatory, manufacturing & commercialization, while Vivtex will receive an upfront, research funding, & milestone payments totalling…
3 days ago

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NEWS

Sciwind Biosciences and Pfizer China Partner to Commercialize Ecnoglutide in China

Shots: Sciwind Biosciences has granted Pfizer China exclusive commercialization rights to Ecnoglutide injection in Mainland China As per the deal, Sciwind will retain the MA & will be responsible for R&D, registration, manufacturing, & supply, plus is eligible to receive ~$495M in upfront, regulatory, & sales milestones Independently developed by Sciwind, Ecnoglutide is a cAMP-biased…
5 days ago

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INSIGHTS+

Key Biosimilars Events of January 2026   

Shots:  Global biosimilar activity accelerated across ophthalmology, oncology, immunology, and diabetes, with new or advancing alternatives to Lucentis, Eylea, Stelara, Lantus, Avastin, Opdivo, and Neulasta, expanding patient access across Europe, the US, India, Canada, Ghana, and MENA  Regulatory and commercialization momentum remained strong, marked by FDA, EC, Health Canada, and Ghana FDA milestones, alongside Samsung Bioepis’…
February 3, 2026

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NEWS

CivicaScript Launches Insulin Glargine-yfgn and Ustekinumab-aauz (Biosimilar, Lantus and Stelara) in the US  

Shots:  CivicaScript has reported that Insulin Glargine-yfgn and Ustekinumab-aauz, biosimilar versions of Lantus and Stelara, are now available in the US  Civica insulin glargine-yfgn is an interchangeable Lantus® insulin for adults and children with diabetes, developed through a Civica-led collaboration. It is marketed nationally by CivicaScript and branded as CalRx in California through the state’s CalRx program  Ustekinumab-aauz is an IL-12/23 antagonist indicated for select…
January 5, 2026

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INSIGHTS+

Key Biosimilars Events of November 2025  

Shots:        Regulatory momentum accelerates globally, with major approvals across the US, EU, UK, and Canada for biosimilars targeting high-value biologics such as Simponi, Stelara, Perjeta, Prolia/Xgeva, Remicade, Xolair, Eylea, Lucentis, and Lantus SoloStar, strengthening patient access in immunology, oncology, ophthalmology, diabetes, and allergy/asthma  Sandoz, Alvotech, Celltrion, Henlius/Organon, Teva, and others expand portfolios and market reach, including multiple EC and…
December 2, 2025

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Novo-Nordisk
NEWS

Novo Nordisk Reports the US FDA’s sNDA Submission for Higher Wegovy Dose for Weight Management

Shots: The US FDA has received an sNDA for a higher dose of Wegovy (7.2mg semaglutide) along with lifestyle intervention for chronic weight management in adults with obesity, with sNDA to be reviewed under CNPV program sNDA was supported by 72wk. STEP UP trial assessing Wegovy (7.2mg, QW) vs Wegovy (2.4mg) & PBO alongside lifestyle intervention in 1,407 obese…
November 27, 2025

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Biocon Biologics & Civica
NEWS

Biocon Biologics and Civica Partner to Launch Private-Label Insulin Glargine in the US

Shots: Biocon Biologics has expanded its strategic collaboration with Civica to commercialize Insulin Glargine in the US Biocon Biologics & Civica entered into a multi-year exclusive distributorship where Biocon will manufacture & supply Insulin Glargine, & Civica will handle its commercialization in the US under its own label, incl. the CalRx brand in California No…
October 16, 2025

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