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INSIGHTS+

Key Biosimilars Events of October 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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NEWS

Regeneron Enters a ~$2B In-Licensing Deal with Hansoh Pharma for HS-20094, Expanding its Obesity Portfolio

Shots: Regeneron has entered into an in-licensing agreement with Hansoh for exclusive global clinical development & commercialization rights of HS-20094, excl. Mainland China, Hong Kong & Macau As per the deal, Hansoh will receive $80M upfront & ~$1.93B in development, regulatory & sales milestones, with low double digits royalties on sales in Regeneron-licensed areas HS-20094…
June 3, 2025

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ThoughtSpot_Igor Zagradanin4
THOUGHTSPOT

Managing Chronic Conditions: Medication, Supplements, and Personalized Care Plans

Statistics show that at least 129 million people in the United States have a chronic illness. To effectively deal with chronic illnesses, one needs a thorough approach that includes customized supplements and medication. The management of these prolonged conditions requires consistent attention to prevent complexities while ensuring better living standards for patients. Continue reading to learn about…
July 26, 2024

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VIEWPOINTS_Paul K Owens_2023
VIEWPOINTS

Paul K Owens, VP of Global Brand Development, Insulins & Glucagon at Eli Lilly & Company Shares Insights from the US FDA Approval of Lyumjev

Shots: Paul talked about the approval of the Lyumjev Injection for the improvement of glycemic control in children and adolescents with diabetes. He also shared various details about Lyumjev Paul further discussed the study design and the key findings from the registrational PRONTO-Peds study The interview also talks about Lilly’s Diabetes Solution Center which helps eligible…
April 20, 2023

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VIEWPOINTS_Jason-Winnike_2023
VIEWPOINTS

Jason Winnike, Study Director at Metabolon Shares Insights from the Launch of its Oxysterol Targeted Panel

Shots: Jason shared his views on the launch of Metabolon, Inc.’s new Oxysterols Targeted Panel, highlighting its key features  He told how the panel measures 12 oxysterols and related sterols of biological significance to identify biomarkers for the prediction and early detection of cardiovascular diseases, neurodegenerative diseases, and cancer  The interview gives a profound understanding…
March 6, 2023

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