Bio-Thera Reports the US FDA’s BLA Acceptance of BAT2506 (Biosimilar, Simponi)

Shots: FDA has accepted BLA for BAT2506, a biosimilar of Simponi (golimumab) for all approved doses, formulations, & indications of reference product, with a request for interchangeability (BsUFA: May 16, 2026) BLA was backed by extensive analytical characterization & biosimilarity of BAT2506 in comparison to US & EU Simponi from P-I trial in healthy subjects,…

ByRidhi RastogiJuly 17, 2025

NEWS

Biocon Biologics’ Kirsty (Biosimilar, NovoLog) Secures the US FDA’s Approval

Shots: The US FDA has approved Kirsty (100 units/mL), an interchangeable biosimilar of NovoLog (Insulin Aspart) to improve glycemic control in adults & pediatric pts with diabetes mellitus Approval was based on comprehensive analytical, non-clinical, & clinical data, which showed similar efficacy, safety, purity & potency of Kirsty vs NovoLog Kirsty is a rapid-acting human…

ByRidhi RastogiJuly 16, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Jul 07, 2025 – Jul 11, 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:  PulseSight Therapeutics Reports First Patient Dosing with PST-611 in P-I (PST-611-CT1) Trial for Dry AMD/Geographic Atrophy  Read More: PulseSight Therapeutics BioAtla Presents Preliminary P-I Trial Data of BA3182 in Patients with…

ByRidhi RastogiJuly 11, 2025

NEWS

Lupin Joins Forces with Zentiva to Develop TNF-Alpha Inhibitor Biosimilar

Shots: Zentiva has entered into a license & supply agreement with Lupin to commercialize Lupin's TNF-alpha inhibitor biosimilar across multiple global markets Zentiva will lead commercialization outside the US & Canada, mainly in EU & CIS, while Lupin will handle development, manufacturing, & supply in agreed territories & commercialization in the remaining territories, incl. the…

ByRidhi RastogiJuly 9, 2025

NEWS

Celltrion Launches Osenvelt and Stoboclo (Biosimilars, Xgeva and Prolia) in the US

Shots: Celltrion has launched Osenvelt & Stoboclo, biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) in the US Stoboclo (60mg/mL) treats postmenopausal women & men with osteoporosis at high fracture risk, glucocorticoid-induced osteoporosis in both sexes, & increases bone mass in men on androgen deprivation therapy for nonmetastatic prostate cancer & women on adjuvant aromatase inhibitors…

ByRidhi RastogiJuly 8, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Jun 30, 2025 – Jul 04, 2025)   

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, and Biosimilar. Check out our full report below:  Neurocrine Reports Data From KINECT-HD Study Evaluating INGREZZA in Huntington’s Disease (HD) Read More: Neurocrine UCB Reports the P-III Data of Fenfluramine in CDKL5 Deficiency Disorder (CDD) Patients Read More: UCB …

ByRidhi RastogiJuly 4, 2025

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…

ByDipanshu DixitJuly 4, 2025

NEWS

mAbxience Reports the EC’s Approval of Denbrayce and Izamby (Biosimilar, Xgeva and Prolia)

Shots: The EC has approved Denbrayce & Izamby, biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) following the CHMP’s recommendation Denbrayce prevents skeletal-related events in adults with bone-involved malignancies & treats giant cell tumors of bone in adults & skeletally mature adolescents Izamby is indicated to treat osteoporosis in postmenopausal women & men at increased risk…

ByRidhi RastogiJuly 3, 2025

NEWS

Apotex Receives Health Canada Approval for Aflivu (Biosimilar, Eylea)

Shots: Apotex has reported Health Canada's approval of Aflivu (aflibercept), a biosimilar to Eylea in PFS and vials Aflivu is indicated for wet age-related macular degeneration, macular edema from retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization Aflivu expands Apotex's biosimilar portfolio, which already includes Grastofil (filgrastim), Lapelga (pegfilgrastim), and Bambevi (bevacizumab) Ref: PRNewsWire | Image:…

ByDipanshu DixitJuly 2, 2025

NEWS

Alvotech Partners with Advanz Pharma to Commercialize AVT10 (Biosimilar, Cimzia) in the EU

Shots: Alvotech has entered into a supply & commercialization agreement with Advanz Pharma for AVT10, a biosimilar version of Cimzia (certolizumab pegol) Alvotech & Advanz Pharma have previously partnered on biosimilars for over 10 reference biologics, with a plan to launch their first biosimilars in the EU by Q4’25 Cimzia binds with both soluble &…

ByRidhi RastogiJuly 2, 2025

Bio-Thera Reports the US FDA’s BLA Acceptance of BAT2506 (Biosimilar, Simponi)

Biocon Biologics’ Kirsty (Biosimilar, NovoLog) Secures the US FDA’s Approval

PharmaShots Weekly Snapshots (Jul 07, 2025 – Jul 11, 2025)

Lupin Joins Forces with Zentiva to Develop TNF-Alpha Inhibitor Biosimilar

Celltrion Launches Osenvelt and Stoboclo (Biosimilars, Xgeva and Prolia) in the US

PharmaShots Weekly Snapshots (Jun 30, 2025 – Jul 04, 2025)

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

mAbxience Reports the EC’s Approval of Denbrayce and Izamby (Biosimilar, Xgeva and Prolia)

Apotex Receives Health Canada Approval for Aflivu (Biosimilar, Eylea)

Alvotech Partners with Advanz Pharma to Commercialize AVT10 (Biosimilar, Cimzia) in the EU

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