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INSIGHTS+

Key Biosimilars Events of May 2026 

Shots:  May 2026 saw strong biosimilar momentum with key approvals including Bevqolva (Health Canada), Langlara and Immgolis/Immgolis Intri (US FDA), Bysumlog and Dazparda (EC), and Eyzanfy (MFDS), expanding competition across oncology, diabetes, immunology, and ophthalmology.  Strategic progress continued with Henlius’ FDA IND clearance for HLX05-N, alongside partnerships between IQVIA–Kexing Biopharm and Polpharma–Tuteur, supporting global development and commercialization efforts.  Commercialization accelerated through the EU launches of FYB203 and Opuviz, as well as Samsung Bioepis’ ustekinumab biosimilar launch in Japan,…
June 2, 2026

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CuraTeQ
NEWS

CuraTeQ Biologics Receives Health Canada Approval for  Bevqolva (Biosimilar, Avastin) 

Shots:  Health Canada has granted NOC to Bevqolva (bevacizumab), a biosimilar version of Genentech’s Avastin  Bevacizumab, a humanized mAb, inhibits angiogenesis by blocking VEGF-A to slow tumor vascular growth in cancers like colorectal and lung. Marketed by Roche/Genentech as Avastin, it is available in 100 mg and 400 mg formulations  In 2025, Bevqolva received MHRA approval and was launched in the…
May 1, 2026

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CuraTeQ
NEWS

CuraTeQ Biologics Reports the Health Canada’s NOC for Dyrupeg (Biosimilar, Neulasta) 

Shots:  CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, has received NOC from the BRDD for Dyrupeg, a biosimilar to Neulasta (pegfilgrastim)  Dyrupeg (pegfilgrastim) is a long-acting form of filgrastim that mimics human G-CSF, stimulating bone marrow to increase white blood cell production and treat neutropenia  In 2025, Dyrupeg received marketing authorization from the EC and the UK MHRA, with three additional CuraTeQ biosimilar…
January 9, 2026

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CuraTeQ
NEWS

CuraTeQ Biologics Reports Positive P-III study results for Denosumab biosimilar for postmenopausal osteoporosis 

Shots:  CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, reported positive P-III results for its denosumab biosimilar targeting postmenopausal osteoporosis, as an alternative to Prolia  The study involved 446 postmenopausal women across 40 sites in EU met all EPs, showing no significant differences between the biosimilar and Prolia  The trial confirmed the biosimilar's efficacy in improving…
September 19, 2025

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CuraTeQ
NEWS

The EC Approves CuraTeQ Biologics’ Dazublys (Biosimilars, Herceptin)   

Shots:  CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, reported EC’s approval of Dazublys, its trastuzumab biosimilar following the CHMP’s recommendation in Apr 2025  The approval was based on its demonstrated similarity to Herceptin in PK, PD, efficacy, safety, and immunogenicity  Dazublys is approved for HER2-positive breast and gastric cancers, and expanding access to treatment across…
July 4, 2025

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CuraTeQ
NEWS

CuraTeQ Biologics Receives CHMP’s Positive Opinion for Dazublys (Biosimilar, Herceptin) 

Shots:  CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, reported EMA’s CHMP has granted a positive opinion to Dazublys (150 mg powder for concentrate for solution for infusion), its trastuzumab biosimilar, to treat HER2-positive metastatic and early breast cancers. Pending expected EC approval in July, it will be available across the EU member states  The opinion…
April 26, 2025

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