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NEWS

Gan & Lee Pharmaceuticals Receives the CHMP Positive Opinion for Bysumlog and Dazparda (Biosimilar, Humalog and NovoRapid) 

Shots:  The CHMP has recommended marketing authorization for Bysumlog (insulin lispro) and Dazparda (insulin aspart), a biosimilar version of Humalog and  NovoRapid, respectively, across all 30 EEA states  Opinion was supported by P-I demonstrating biosimilarity and comparable safety of Bysumlog vs Humalog and Dazparda vs NovoLog/NovoRapid.  Gan & Lee Pharmaceuticals signed a development, license, and commercialization agreement with Sandoz for three insulin biosimilars: glargine, lispro, and aspart. Upon approval, Sandoz…
February 27, 2026

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Joshua Salsi from Biocon Biologics in a Riveting Conversation with PharmaShots
VIEWPOINTS

Unlocking Approval: Joshua Salsi from Biocon Biologics in a Riveting Conversation with PharmaShots 

Shots:  The United States has about 38.4 million people living with diabetes, representing 11.6% of the total population. With growing prevalence, there is a significant unmet need for affordable diabetes medications.  Biocon Biologics recently announced the FDA approval of Kirsty, the first and only interchangeable biosimilar to NovoLog (Insulin Aspart).  Joshua Salsi, the Head of…
September 8, 2025

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NEWS

Biocon Biologics’ Kirsty (Biosimilar, NovoLog) Secures the US FDA’s Approval

Shots: The US FDA has approved Kirsty (100 units/mL), an interchangeable biosimilar of NovoLog (Insulin Aspart) to improve glycemic control in adults & pediatric pts with diabetes mellitus Approval was based on comprehensive analytical, non-clinical, & clinical data, which showed similar efficacy, safety, purity & potency of Kirsty vs NovoLog Kirsty is a rapid-acting human…
July 16, 2025

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