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INSIGHTS+

Key Biosimilars Events of September 2026  

Shots:   Sep 2026 saw key biosimilar developments across oncology, immunology, diabetes, and bone disorders, with companies including Cipla, Samsung Bioepis, Biocon, Henlius, Teva, and STADA advancing approvals, regulatory filings, and partnerships.   Major developments included FDA approvals for Teva’s Degevma (denosumab) and Meitheal’s high-concentration Yusimry (adalimumab), alongside CHMP’s positive opinion for Biocon Biologics’ Pebrilzo (pertuzumab) and…
3 days ago

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INSIGHTS+

Key Biosimilars Events of August 2026 

Shots:  In August, biosimilar approvals and launches gained strong momentum with Biocon’s Yesafili (Eylea) and Yesintek (Stelara), FDA approval of rituximab from Dr. Reddy’s and Fresenius Kabi, and Celltrion’s European launch of Omlyclo (Xolair).   Global licensing and commercialization partnerships continued to drive biosimilar expansion with collaborations spanning North America, Europe, ASEAN, and MENA markets.   The biosimilar pipeline continued to broaden across key therapeutic…
September 1, 2026

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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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