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INSIGHTS+

Key Biosimilars Events of February 2026 

Shots:  Regulatory momentum accelerated globally with multiple biosimilars securing key approvals and positive opinions, including Sandoz’s Enzeevu (Eylea biosimilar) in the US and Canada, Accord BioPharma’s Filkri (Neupogen biosimilar) US FDA approval, EC approvals for Gotenfia (Simponi biosimilar) and Ranluspec (Lucentis biosimilar), and CHMP positive opinions for tocilizumab and insulin biosimilars.  Strategic partnerships expanded regional access as companies including Alvotech, Bio-Thera Solutions, Formycon,…
March 3, 2026

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NEWS

Bio-Thera Partners with Avalon Pharma to Commercialize BAT3306 (Biosimilar, Keytruda) in Saudi Arabia and MENA 

Shots:  Bio-Thera and Avalon Pharma have signed commercialization and licensing agreements for BAT3306, a biosimilar version of Keytruda (Pembrolizumab)  As per the deal, Bio-Thera will oversee development, manufacturing, and supply of BAT3306, while Avalon Pharma will handle regulatory approvals and commercialization across Saudi Arabia and the MENA region  BAT3306 is a humanized monoclonal antibody and immune checkpoint inhibitor…
February 3, 2026

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Bio-Thera New
NEWS

Bio-Thera Solutions Reports the Initiation of Combined P-I/P-III Study of BAT3306 (Biosimilar, Keytruda)

Shots:    Bio-Thera Solutions has commenced the patients dosing under the combined P-I/P-III study evaluating BAT3306, a biosimilar version of Keytruda (pembrolizumab)  The trial aims at assessing PK profile, safety & efficacy of BAT3306 vs Keytruda among patients (n=676) with non-squamous non-small cell lung cancer (nsNSCLC)  In addition, the company is also developing biosimilars of…
July 25, 2024

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