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NEWS

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…
October 3, 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 productApproval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed comparable immunogenicity, efficacy & safety of Bildyos & Bilprevda to reference denosumabIn 2022, Henlius…
September 22, 2025

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NEWS

STADA Receives the CHMP’s Positive Opinion for Kefdensis and Zvogra (Biosimilar, Prolia & Xgeva)  

Shots: The CHMP has recommended Kefdensis and Zvogra, a biosimilar version of Amgen’s Prolia & Xgeva (denosumab) for the treatment of bone & skeletal disorders Kefdensis (biosimilar to Prolia) received CHMP approval for treating osteoporosis in high-risk postmenopausal women and men with an increased risk of fractures. Zvogra (biosimilar to Xgeva) received CHMP approval for preventing skeletal events…
September 19, 2025

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NEWS

Alvotech Reports Marketing Approval of Three New Biosimilars Across Japan 

Shots: Alvotech has reported that its partner Fuji Pharma has received Japanese approval for three biosimilars: AVT03 (Biosimilar, Ranmark), AVT05 (Biosimilar, Simponi), and AVT06 (Biosimilar, Eylea)  In Japan, AVT03 (denosumab-biosimilar to Ranmark/Xgeva) was approved for bone lesions from multiple myeloma or solid tumor metastases; AVT05 (golimumab biosimilar to Simponi) for rheumatoid arthritis Pts. who are…
September 19, 2025

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Celltrion
NEWS

Celltrion Receives the Health Canada’s Approval for Stoboclo and Osenvelt (Biosimilar, Prolia & Xgeva)

Shots:Health Canada has approved Stoboclo & Osenvelt (CT-P41), referencing biosimilar Prolia & Xgeva, for all approved indications of the reference drugsApproval was supported by P-III trial data in postmenopausal women with osteoporosis (PMO), showing CT-P41 matched reference denosumab in efficacy & PD, with similar PK, safety, and immunogenicityStoboclo and Osenvelt are RANKL…
September 19, 2025

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NEWS

Biocon Biologics Receives the FDA’s Approval & Provisional Interchangeability Designation for Aukelso and Bosaya (Biosimilars, Xgeva and Prolia)

Shots:The US FDA has approved & granted provisional interchangeability designation to Aukelso (70mg/mL, SC, single-dose vial) & Bosaya (60mg/mL, SC, PFS), biosimilar versions of Amgen’s Xgeva & Prolia (denosumab)Clinical data showed both biosimilars matched the reference product in quality, safety & efficacy, plus Bosaya was approved with Prolia’s REMS to inform about sev. hypocalcemia…
September 18, 2025

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TOP 20

Top 20 Oncology Companies of 2025 

Shots: ADCs, cell therapies, and radioligand therapies are reshaping oncology, while biopharma companies focus on smarter trials, patient-first approaches, and faster access to bridge unmet needs in cancer care In 2024, the global oncology market was valued at $225.01B and is projected to reach $668.26B by 2034, reflecting a strong CAGR of 11.5% from 2025…
September 3, 2025

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Henlius & Organon
NEWS

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

Shots:The US FDA has approved Bildyos (60mg/mL) & Bilprevda (120mg/1.7mL), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab) for all indications of the reference productApproval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed comparable quality, efficacy & safety of Bildyos & Bilprevda to reference denosumabIn 2022,…
September 3, 2025

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