Skip to content Skip to footer
Subscribe Now
NEWS

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 2025 Approval was based on the comprehensive clinical data, which showed comparable PK, safety, efficacy & immunogenicity of Vevzuo & Evfraxy to the reference product Vevzuo prevents SREs in adults with bone-involved malignancies…
July 4, 2025

Read more

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…
July 3, 2025

Read more

Fresenius Kabi
NEWS

Fresenius Kabi Launches Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva) in the US 

Shots:  Fresenius Kabi launched Conexxence and Bomyntra, biosimilar of Prolia & Xgeva (denosumab) for all indications of the reference products across the US  Conexxence (denosumab-bnht) 60 mg/mL, available in PFS, is approved for adults at high risk of fractures, including those with osteoporosis, pts. on cancer treatments affecting bone density, or long-term glucocorticoids   Bomyntra (denosumab-bnht)…
July 1, 2025

Read more

Sandoz
NEWS

Sandoz Reports EC’s Approval of Wyost and Jubbonti (Biosimilars, Xgeva and Prolia) 

Shots:  The EC has granted approval to the company’s Wyost and Jubbonti, biosimilar of Xgeva and Prolia (denosumab), across the EU for treating same indications as that of Xgeva and Prolia incl. cancer-related bone disease & osteoporosis, respectively. Their launch is anticipated from Nov 2025 onwards  The EC’s approval was supported by the clinical evaluations…
June 23, 2025

Read more

Sandoz
NEWS

Sandoz Launches Wyost and Jubbonti (Biosimilars, Xgeva and Prolia) in the US

Shots: Sandoz has launched Wyost & Jubbonti, interchangeable biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) in the US Jubbonti (60mg/1mL) 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…
June 2, 2025

Read more

Biocon Biologics
NEWS

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 reference Denosumab is a mAb that works by targeting…
April 29, 2025

Read more

Gedeon Richter
NEWS

Gedeon Richter Receives CHMP’s Positive Opinion for Junod and Yaxwer (Biosimilars, Prolia and Xgeva) 

Shots:  The CHMP has recommended marketing authorization for Junod and Yaxwer, biosimilars of Amgen’s Xgeva & Prolia (denosumab)  Denosumab is approved to treat postmenopausal osteoporosis, prevent bone complications from cancer metastases, and treat unresectable giant cell tumors of bone  Junod & Yaxwer are mAbs (IgG2) that block RANKL, preventing osteoclast activation   Ref: Gedeon Richter | Image: Gedeon Richter…
April 25, 2025

Read more

Top 20 Biopharma 2025
TOP 20

Top 20 Biopharma Companies of 2025 

Shots:  Driven by innovation and a steadfast commitment to advancing cutting-edge therapies, the biopharma industry experienced robust growth in 2024, marked by significant revenue milestones  With a projected compound annual growth rate (CAGR) of 12.87%, the global biopharma market is expected to reach $1.41 trillion by 2032. In 2024, Pfizer led the industry with total…
April 24, 2025

Read more

Accord Healthcare
NEWS

Accord Healthcare Reports the CHMP’s Positive Opinion on Osvyrti and Jubereq (Biosimilar, Prolia & Xgeva)

Shots: The CHMP has recommended Osvyrti & Jubereq, biosimilar versions of Amgen’s Prolia & Xgeva (denosumab); launch expected post patent expiry of reference products in Nov 2025 Osvyrti (60mg pre-filled syringe) is indicated to treat osteoporosis in postmenopausal women & men at increased risk of fractures. It also used to treat bone loss in pts…
April 3, 2025

Read more

Fresenius Kabi
NEWS

The US FDA Approves Fresenius’ Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva)

Shots: The US FDA has approved BLA of Conexxence & Bomyntra, biosimilar versions of Prolia & Xgeva (denosumab) for all indications of the reference products Approval was supported by extensive analytical development & similarity assessment based on 2 trials: one assessing its PK, PD, & immunogenicity in healthy volunteers, & other evaluating its efficacy, PD, safety,…
March 27, 2025

Read more

Load more