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INSIGHTS+

Key Biosimilars Events of March 2026 

Shots:  Regulatory momentum remained strong, with key biosimilar launches and approvals including Celltrion’s Remsima IV (EU) and Avtozma SC (US), Teva’s FDA-approved Ponlimsi, Japan’s approval of tocilizumab BS MA by Mochida Pharmaceutical and AYUMI Pharmaceutical, and IND clearance for HLX18 by National Medical Products Administration.  Strategic partnerships expanded access, led by Samsung Bioepis–Sandoz collaboration, Formycon’s aflibercept settlement deal with Regeneron Pharmaceuticals and Bayer, and Bio-Thera…
April 7, 2026

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Celltrion
NEWS

Celltrion Introduces Remsima IV Liquid Formulation (Biosimilar, Remicade) in the EU 

Shots:  Following the EU approval of Remsima IV in Nov’25, Celltrion launched Remsima IV, a biosimilar version of Remicade (Infliximab), across Europe  Celltrion has filed and secured patents for the Remsima liquid formulation across most EU countries, including key markets such as the UK, Germany, and France  The Remsima liquid formulation adds to existing IV (100 mg lyophilized) and SC options, aligning with clinical demand in Europe…
March 11, 2026

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Celltrion
NEWS

Celltrion Receives EC Approval for Remsima IV (Biosimilar, Remicade)  

Shots:  The EC has approved Remsima IV (100mg and 350mg vials), a liquid formulation, a biosimilar version of Remicade   The approval is supported by data showing the liquid and powder infliximab formulations are comparable in CMC characteristics and stability after reconstitution and dilution   The Remsima IV liquid formulation is EU-approved for all existing IV infliximab indications, including RA, adult and pediatric CD and UC,…
November 18, 2025

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