Key Biosimilars Events of July 2026

Shots: July 2026 witnessed strong momentum across the biosimilars landscape with major regulatory approvals, including Ennumo (US FDA), Garzulys (US FDA), Yesintek Autoinjector (Health Canada), and FDA/EMA acceptance of PB016, alongside commercial launches of Byooviz, Osvyrti, and Jubereq, expanding treatment options across oncology, ophthalmology, immunology, osteoporosis, diabetes, and inflammatory diseases. Strategic collaborations and licensing agreements between Orion Pharma–Shilpa Biologicals, Polpharma–Teva, Samsung Bioepis–Teva, Formycon–OneSource Specialty Pharma, and Organon–Samsung Bioepis strengthened…

ByDipanshu DixitAugust 4, 2026

NEWS

FiberSense Receives CE Mark for its Continuous Glucose Monitoring (CGM) System

Shots: FiberSense has received the CE Marking for its CGM System as a Class IIb medical device, with the company planning to launch in select markets, with initial orders confirmed & first deliveries expected in late 2026 The company is preparing manufacturing scale-up, logistics, customer support, & market access activities for launch, while advancing its…

ByRidhi RastogiJune 17, 2026

NEWS

Eli Lilly Reports P-III (TRIUMPH-1) Trial Data on Retatrutide for Weight Management

Shots: Trial assessed Lilly’s retatrutide (4, 9 & 12mg) with dose escalation vs PBO in adults with obesity/overweight & ≥1 weight-related comorbidity & without diabetes, meeting 1EP of 19% (4mg), 25.9% (9mg) & 28.3% (12mg) weight loss at 80wks. In 2EPs, retatrutide reduced waist circumference by 16.3cm (4mg), 21.8cm (9mg), & 24.1cm (12mg) vs 3.6cm.…

ByRidhi RastogiMay 21, 2026

NEWS

Novo Nordisk Reports the US FDA Approval of Wegovy HD for Weight Management

Shots: FDA has approved Wegovy HD (7.2mg semaglutide, QW) under CNPV along with lifestyle intervention for chronic weight management in adults with obesity; Wegovy HD will be launched as a single-dose pen by Apr 2026 Backed by STEP UP trial (~1,400 adults without T2D) & STEP UP T2D trial (~500 obese adults with T2D), based…

ByRidhi RastogiMarch 23, 2026

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…

ByRidhi RastogiFebruary 26, 2026

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…

ByRidhi RastogiFebruary 24, 2026

NEWS

Novo Nordisk Reports EC Approval of Higher Injectable Wegovy Dose for Weight Management

Shots: The EC has approved a higher maintenance dose of Wegovy (7.2mg semaglutide; QW) for chronic weight management in adults with obesity across 27 EU countries Assessed in STEP UP trial (1,407 adults without diabetes) & STEP UP T2D (512 adults with obesity & T2D) trial, Wegovy 7.2mg achieved 21% mean weight loss vs ~2%…

ByRidhi RastogiFebruary 18, 2026

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’…

ByDipanshu DixitFebruary 3, 2026

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…

ByDipanshu DixitJanuary 5, 2026

NEWS

Eli Lilly Reports P-III (TRIUMPH-4) Trial Data on Retatrutide for Weight Management

Shots: Trial assessed Lilly’s retatrutide (9 & 12mg) + lifestyle intervention in adults with obesity or overweight & knee osteoarthritis, & without diabetes, meeting its co-1EPs with 26.4% (9mg) & 28.7% (12mg) vs 2.1% weight loss & reduced WOMAC pain by 4.5 & 4.4 vs 2.4 points It also reduced known CV risk markers &…

ByRidhi RastogiDecember 12, 2025

Key Biosimilars Events of July 2026

FiberSense Receives CE Mark for its Continuous Glucose Monitoring (CGM) System

Eli Lilly Reports P-III (TRIUMPH-1) Trial Data on Retatrutide for Weight Management

Novo Nordisk Reports the US FDA Approval of Wegovy HD for Weight Management

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

Sciwind Biosciences and Pfizer China Partner to Commercialize Ecnoglutide in China

Novo Nordisk Reports EC Approval of Higher Injectable Wegovy Dose for Weight Management

Key Biosimilars Events of January 2026

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

Eli Lilly Reports P-III (TRIUMPH-4) Trial Data on Retatrutide for Weight Management

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