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Biocon Biologics Receives the EC’s Approval for Vevzuo and Evfraxy (Biosimilars, Xgeva and Prolia)

Shots:The EC has approved Vevzuo & Evfraxy, biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) following the CHMP positive opinion in Apr 2025Approval was based on the comprehensive clinical data, which showed comparable PK, safety, efficacy & immunogenicity of Vevzuo & Evfraxy to the reference productVevzuo prevents SREs in adults with bone-involved malignancies…
July 4, 2025

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Biocon Biologics
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Biocon Biologics Receives CHMP’s Positive Opinion for Vevzuo and Denosumab BBL (Biosimilars, Xgeva and Prolia)

Shots:The CHMP has recommended Vevzuo & Denosumab BBL (brand name under approval), biosimilars of Xgeva & Prolia (denosumab)Opinion was based on the comprehensive clinical data submitted by Biosimilar Collaborations Ireland (Biocon Biologics’ subsidiary) incl. trials, which showed comparable PK, safety, efficacy & immunogenicity to the referenceDenosumab is a mAb that works by targeting…
April 29, 2025

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Biocon Biologics
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Biocon Biologics and Regeneron Settle over Yesafili’s (Biosimilar, Eylea) US Launch

Shots:Biocon Biologics & Regeneron have entered into a settlement & license agreement, allowing the US launch of Yesafili, an interchangeable biosimilar version of Eylea (aflibercept) by H2’26Yesafili’s FDA approval was supported by analytical, nonclinical & clinical data incl. P-III (INSIGHT) trial assessing Yesafili vs Eylea in DME pts, confirming its similarity in PK,…
April 16, 2025

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Viewpoints_Uwe Gudat
VIEWPOINTS

Biocon Biologics at AAO 2024: Uwe Gudat in an Invigorating Discussion with PharmaShots

Shots:At the American Academy of Ophthalmology (AAO 2024), Biocon Biologics announced promising results from the extension study of its proposed biosimilar to aflibercept, MYL-1701PThe study demonstrated comparable safety, efficacy, and immunogenicity between patients continuing MYL-1701P and those who switched from aflibercept to MYL-1701PBiocon Biologics' Chief Medical Officer, Uwe Gudat, discusses the groundbreaking…
March 17, 2025

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Biocon Biologics
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Biocon Biologics Report the P-III Study Positive Results of Yesintek (Biosimilar, Stelara) 

Shots: Biocon Biologics revealed positive results from the P-III study demonstrating that Yesintek achieved equivalent efficacy, safety, immunogenicity, and PK vs reference product to treat mod. to sev. chronic plaque psoriasis (PsO) pts. (n=384, age= 18-80yrs.); data was presented at AAD 2025 The primary efficacy endpoint, percentage change in PASI scores at Wk. 12 showed…
March 7, 2025

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Key Biosimilars Events of December 2024
INSIGHTS+

Key Biosimilars Events of December 2024

Shots:Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients A major highlight was the US FDA’s approval of Biocon Biologics’ Yesintek…
January 7, 2025

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