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NEWS

Gedeon Richter and Hikma Pharmaceuticals Receive the US FDA’s Approval for Enoby and Xtrenbo (Biosimilar, Prolia & Xgeva)

Shots: The US FDA has approved Enoby (RGB-14-P) & Xtrenbo (RGB-14-X), biosimilar versions of Prolia & Xgeva (denosumab) for the treatment of bone & skeletal disorders Approval was based on extensive clinical data submitted by Hikma, incl. analytical, non-clinical & clinical studies, which showed comparable quality, efficacy, safety & immunogenicity of Enoby & Xtrenbo to reference…
September 29, 2025

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NEWS

Amneal Pharmaceuticals Reports the US FDA’s BLA Filing for Biosimilar Candidate to Xolair (Omalizumab)

Shots: The US FDA has received a BLA for a biosimilar candidate to Novartis’ Xolair (omalizumab), developed by Kashiv BioSciences Additionally, Amneal expects to incur a $22.5M R&D milestone charge in Q3’25 instead of Q4 due to the earlier BLA filing & holds exclusive US commercialization rights for the product pending regulatory approval Xolair is…
September 29, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Sep 22, 2025 – Sep 26, 2025)  

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A and Biosimilars. Check out our full report below:   Roche Reports P-III (evERA Breast Cancer) Trial Data on Giredestrant + Everolimus for ER-Positive Breast Cancer Read More: Roche BMS Reports the P-III (EXCALIBER-RRMM) Trial Data of Iberdomide Regimen to Treat…
September 26, 2025

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NEWS

Kashiv BioSciences and JAMP Pharma Launch Pexegra (Biosimilar, Neulasta) and Filra (Biosimilar, Neupogen) in Canada

Shots: Kashiv BioSciences & JAMP Pharma have launched Pexegra & Filra, biosimilar version of Neulasta & Neupogen, respectively, in Canada JAMP Pharma & Kashiv BioSciences entered an exclusive agreement to market Pexegra & Filra in Canada, with Kashiv’s facilities supporting JAMP’s commercialization efforts Pexegra (6mg/0.6mL) & Filra (300mcg/0.5mL & 480mcg/0.8mL) help treat CT-induced neutropenia by…
September 25, 2025

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NEWS

Alvotech’s Gobivaz (Biosimilar, Simponi) Receives the CHMP’s Positive Opinion to Treat Several Chronic Inflammatory Diseases

Shots: The CHMP has recommended Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis, PsA, ankylosing spondylitis & ulcerative colitis in adult pts & juvenile idiopathic arthritis across 30 EEA states In trials, Gobivaz demonstrated comparable efficacy, safety, & immunogenicity to Simponi in pts…
September 24, 2025

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NEWS

Alkem Laboratories launches Pertuza (Biosimilar, Perjeta) Across India for Treating HER2-Positive Breast Cancer 

Shots:  Alkem Laboratories has launched Pertuza 420mg/14mL, a Perjeta biosimilar, across India for treating HER2-positive breast cancer   In a P-III trial, Pertuza showed equivalent efficacy, safety, and immunogenicity to the reference product   Pertuzumab is a HER2/neu receptor antagonist that was approved for HER2-positive breast cancer  Ref: Alkem Laboratories | Image: Alkem Laboratories | Press Release Related News:- CuraTeQ Biologics Reports…
September 22, 2025

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Henlius & Organon
NEWS

Henlius and Organon Receive the EC’s Approval for Bildyos & Bilprevda (Biosimilars, Prolia & Xgeva)

Shots: The EC has approved Bildyos (60mg/mL) & Bilprevda (120mg/1.7mL), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab) for all indications of the reference product Approval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed comparable immunogenicity, efficacy & safety of Bildyos & Bilprevda to reference denosumab In 2022, Henlius…
September 22, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Sep 15, 2025 – Sep 19, 2025)   

PharmaShots Weekly Snapshots (Sep 15, 2025 – Sep 19, 2025)    This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, COVID-19, M&A and Biosimilars. Check out our full report below:    MAIA Biotechnology Reports P-II (THIO-101) Trial Data of Ateganosine Regimen for Advanced NSCLC  Read More: MAIA Biotechnology  Akeso Reports First…
September 19, 2025

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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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