Biocon Biologics Obtains the US Market Launch Date for Bosaya and Aukelso (Biosimilar, Prolia & Xgeva)

Shots:Biocon Biologics & Amgen have entered into a settlement & license agreement, allowing the US launch of Bosaya (60mg/mL, SC, PFS) & Aukelso (70mg/mL, SC, single-dose vial), provisional interchangeable biosimilars to Prolia & Xgeva (denosumab) by Oct 1, 2025Clinical data showed both biosimilars matched the reference product in quality, safety & efficacy, plus Bosaya…

ByRidhi RastogiOctober 3, 2025

NEWS

BioPorto Launches ProNephro AKI (NGAL) to Detect Acute Kidney Injury in the US

Shots:BioPorto has reported the US launch of the ProNephro acute kidney injury (AKI) test through its collaboration with Roche, following its FDA 510(k) clearance on Roche’s cobas c 501 analyzers for hospital clinical laboratoriesProNephro AKI (NGAL) is an AKI biomarker test for pediatric use (3mos.–21yrs.), which helps identifying ICU pts at risk of…

ByRidhi RastogiAugust 28, 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 USStoboclo (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

NEWS

Johnson & Johnson MedTech Reports the US Launch of VOLT Wrist and Proximal Humerus Plating Systems

Shots:J&J MedTech has launched Variable Angle Optimized Locking Technology (VOLT) Distal Radius (Wrist) & VOLT Proximal Humerus 3.5 Plating System in the USVOLT Wrist, developed with the AO Technical Commission, features the VOLT Two-Column Distal Radius Rim Plate with a new shape that sits more distal to target fragments & is less prominent…

ByRidhi RastogiJune 20, 2025

Biocon Biologics Obtains the US Market Launch Date for Bosaya and Aukelso (Biosimilar, Prolia & Xgeva)

BioPorto Launches ProNephro AKI (NGAL) to Detect Acute Kidney Injury in the US

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

Johnson & Johnson MedTech Reports the US Launch of VOLT Wrist and Proximal Humerus Plating Systems

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