Denosumab

Phase 3 Comparative Clinical Study of Prolia® and Xgeva® (denosumab) Biosimilar Candidate HLX14 Met Primary Endpoints

Retrieved on: 
Monday, April 8, 2024
Research, Women, Clinical Trials, Biotechnology, Managed Care, General Health, Pharmaceutical, Consumer, Health, Science, Name, Patient, Denosumab, BMD, Woman, Biosimilar, European, Fracture, Osteoporosis, Safety, Multimedia, OGN

Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Prolia® and Xgeva® (denosumab) biosimilar HLX14 met the primary endpoints.

Key Points: 
  • Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Prolia® and Xgeva® (denosumab) biosimilar HLX14 met the primary endpoints.
  • In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates, including HLX14.
  • The agreement covers markets such as the United States, the European Union, and Canada.
  • The primary endpoints of this study were met.

Organon To Report First Quarter 2024 Results and Host Conference Call on May 2, 2024

Retrieved on: 
Monday, April 8, 2024
Biotechnology, Women, Consumer, Health, Pharmaceutical, GAAP, Denosumab, ID, Webcast, IPR, Uncertainty, Research, Biosimilar, EDT, OGN, Broadcasting

Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, will release its first quarter 2024 financial results on May 2, 2024, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EDT.

Key Points: 
  • Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, will release its first quarter 2024 financial results on May 2, 2024, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EDT.
  • Organon currently expects that it will record approximately $15 million of milestone payments in the first quarter of 2024, representing approximately $0.05 to both GAAP and non-GAAP earnings per share.
  • Organon’s first quarter 2024 results have not been finalized and are subject to the company’s quarterly financial statement closing procedures.
  • Accessing First Quarter 2024 Financial Results Webcast:
    Interested parties may access the live call via webcast on the Organon website at https://www.organon.com/investor-relations/events-and-presentations/ .

MAIWEIJIAN, First Approved Biosimilar of Denosumab (120mg) in China

Retrieved on: 
Monday, April 8, 2024
NMPA, Patient, JAMA Oncology, Denosumab, Disability, RANKL, Plasma protein binding, Nephrotoxicity, National Medical Products Administration, Safety, Pharmacokinetics, Kidney, Marketing, Pharmaceutical industry

MAIWEIJIAN is the first denosumab biosimilar (120mg) approved for marketing in China.

Key Points: 
  • MAIWEIJIAN is the first denosumab biosimilar (120mg) approved for marketing in China.
  • Denosumab, due to its demonstrated good therapeutic effects, has been recommended by multiple expert consensuses or treatment guidelines.
  • Doctors and patients have a high level of recognition for denosumab.
  • 3) It has a good safety profile and is not cleared by the kidney, and patients treated with denosumab experience fewer nephrotoxic side effects.

Alvotech Reports Financial Results for Full Year 2023 and Provides a Business Update

Retrieved on: 
Wednesday, March 20, 2024
Joint venture, Patient, Sale, Business analyst, CCHN, IP, Marketing, Research, Mallinckrodt, Absorption, European Economic Area, Gross metropolitan product, Webcast, Asset, Alvogen, Denosumab, Neovascularization, Biosimilar, Macular degeneration, Safety, Food, U.S. FDA, Teva Pharmaceuticals, Revenue, Q3, CES, AMD, FDA, ISK, Administration, Adalimumab, Research and development, Pharmaceutical industry

Management will conduct a business update conference all and live webcast on March 21, 2024 at 8:00 am ET (12:00 pm GMT).

Key Points: 
  • Management will conduct a business update conference all and live webcast on March 21, 2024 at 8:00 am ET (12:00 pm GMT).
  • Alvotech announced positive top-line results from a pharmacokinetic (PK) study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab).
  • Alvotech announced positive top-line results from a PK study for AVT03, a biosimilar candidate to Prolia® and Xgeva®, which both contain denosumab.
  • Alvotech will conduct a business update conference call and live webcast on Thursday, March 21, 2024, at 8:00 am ET (12:00 pm GMT).

Sandoz receives FDA approval for first and only denosumab biosimilars

Retrieved on: 
Tuesday, March 5, 2024
Bone fracture, Fracture, Woman, Hypocalcemia, Osteoporosis, Bone disease, Hypercalcaemia, FDA, Quality of life, Food, Cancer, Denosumab, Metastasis, Risk, Breast, Safety, Mitigation, Novartis, REMS, Benign tumor, Disease, Patent, Patient, Medicine, Multiple myeloma, Ageing, Dietary supplement

Keren Haruvi, President Sandoz North America, said: "Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events, which are disease states that can profoundly reduce quality of life for patients.

Key Points: 
  • Keren Haruvi, President Sandoz North America, said: "Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events, which are disease states that can profoundly reduce quality of life for patients.
  • I am proud that Sandoz continues to pioneer access to these life-changing medicines for the patients who need them most."
  • Wyost® and Jubbonti® have the same dosage form, route of administration, dosing regimen and presentation as the respective reference medicines.
  • Given ongoing patent litigation around these products, Sandoz will not comment on anticipated launch timing or other launch details at this time.

Sandoz receives Health Canada approval for Jubbonti®, first and only denosumab biosimilar for treatment of osteoporosis

Retrieved on: 
Tuesday, February 20, 2024
Health Canada, Denosumab, RANK, Biosimilar, Safety, FRCPC, Novartis, Patient, Osteoporosis, Generic drug

Sandoz continues to expand access for patients in Canada, offering denosumab biosimilar to treat osteoporosis and increase bone mass.

Key Points: 
  • Sandoz continues to expand access for patients in Canada, offering denosumab biosimilar to treat osteoporosis and increase bone mass.
  • Health Canada approval based on robust Phase I and Phase III clinical studies.
  • BOUCHERVILLE, Quebec, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Sandoz Canada is pleased to announce that Health Canada has provided authorization to market Jubbonti® (denosumab subcutaneous injection, reference medicine: Prolia*).
  • Jubbonti® is the first and only Health Canada-approved denosumab biosimilar for osteoporosis and increasing bone mass.

Alvotech Announces Positive Top-Line Results from a Pharmacokinetic Study for AVT03, a Proposed Biosimilar for Prolia® and Xgeva®

Retrieved on: 
Monday, January 29, 2024
Woman, Denosumab, Patient, Biosimilar, Risk, Osteoporosis, Safety, Fracture, Pharmacokinetics, Dietary supplement

The PK study ( AVT03-GL-P01 ), which assessed the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia® in healthy adult subjects, met its primary endpoints.

Key Points: 
  • The PK study ( AVT03-GL-P01 ), which assessed the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia® in healthy adult subjects, met its primary endpoints.
  • A confirmatory efficacy study for AVT03 in patients is currently underway, as well as a PK study comparing AVT03 to Xgeva® in healthy adult subjects.
  • This milestone, and recent positive top-line results from other clinical studies clearly demonstrate our capabilities and the excellence of Alvotech’s biosimilars development platform,” said Joseph McClellan, Chief Scientific Officer.
  • Prolia (denosumab) is indicated for the treatment of osteoporosis in postmenopausal women and for bone loss in adult men and women at increased risk of fracture.

Biosimilars Pipeline Report: Comprehensive Analysis of Prolia & Xgeva Denosumab Candidates Emerges - ResearchAndMarkets.com

Retrieved on: 
Thursday, December 14, 2023
Health, Pharmaceutical, Osteoporosis, Research, Safety, Bone remodeling, RANKL, Patient, Policy, Cancer, Patent, Amgen, Generic drug, Medical imaging, Denosumab

The "Denosumab (Prolia & Xgeva) Biosimilars Pipeline Review" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Denosumab (Prolia & Xgeva) Biosimilars Pipeline Review" report has been added to ResearchAndMarkets.com's offering.
  • Denosumab biosimilars, which are currently under extensive study for their efficacy and safety as potential alternatives to established bone-modifying agents, are at the forefront of this pharmaceutical research wave.
  • The therapeutic agent at the center of this analysis, Denosumab, is a human monoclonal antibody with a specific function to inhibit RANKL, a crucial mediator in bone remodeling.
  • The arrival of this pivotal information will undoubtedly serve as a springboard for strategic decisions and policy development within the burgeoning biosimilars sector.

AMGEN TO PRESENT DATA AT ACR 2023 ACROSS EXPANDED RHEUMATOLOGY PIPELINE AND PORTFOLIO

Retrieved on: 
Wednesday, November 1, 2023
Janus, Online, Woman, Zoledronic acid, Biologic, Rheumatology, Population Health Management, Metabolic bone disease, Spondyloarthropathy, Systemic disease, Thrombosis, MRI, ANCA, Health care, Syndrome, Immunomodulation, Domain, Metabolism, Risk, Vasculitis, Inflammation, Osteoporosis, Adalimumab, Janus kinase inhibitor, Biomarker, Crystal, Rheumatoid arthritis, Alendronic acid, Social, Psoriatic arthritis, Use, Driver, Etanercept, PST, Metric, State, Paint, Pharmaceutical industry, Medical imaging, Health insurance, Book, Dentistry, Dietary supplement, Denosumab, Patient, Hand

THOUSAND OAKS, Calif., Nov. 1, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new scientific and clinical research across its expanded rheumatology pipeline and portfolio, following the recent acquisition of Horizon Therapeutics. More than 20 abstracts will be presented during the American College of Rheumatology (ACR) Convergence 2023, taking place Nov. 10-15, in San Diego.

Key Points: 
  • Abstract #2161, Poster Session C: RA – Treatments Poster III, Tuesday, Nov. 14 from 9-11am PST
    Outcomes in Patients With Rheumatoid Arthritis Initiating Therapy With Etanercept, Adalimumab, or Janus Kinase Inhibitors
    Abstract #0441, Poster Session A: RA – Treatments Poster I, Sunday, Nov. 12 from 9-11am PST
    Treatment-Emergent Major Adverse Cardiovascular and Thromboembolic Events Were Infrequent During Pegloticase Therapy: Pooled Clinical Trial Findings
    Abstract #0236, Poster Session A: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster I, Sunday, Nov. 12 from 9-11am PST
    Oral Urate-Lowering Therapy Use and Efficacy Following Pegloticase Treatment: Findings from a Rheumatology Network Database
    Abstract #0237, Poster Session A: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster I, Sunday, Nov. 12 from 9-11am PST
    Abstract #0239, Poster Session A: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster I, Sunday, Nov. 12 from 9-11am PST
    Abstract #0242, Poster Session A: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster I, Sunday, Nov. 12 from 9-11am PST
    Finding Lost-to-Care Gout Patients in a Large Community Rheumatology Network: Patient Re-engagement Initiative with Metrics (PRIME)
    Abstract #1102, Poster Session B: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster II, Monday, Nov. 13 from 9-11am PST
    Abstract #1103, Poster Session B: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster II, Monday, Nov. 13 from 9-11am PST
    Abstract #1107, Poster Session B: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster II, Monday, Nov. 13 from 9-11am PST
    Abstract #1108, Poster Session B: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster II, Monday, Nov. 13 from 9-11am PST
    Real-world Trends in the Use of Immunomodulation as Co-Therapy to Pegloticase: Claims-Based Findings Since 2016
    Abstract #1123, Poster Session B: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster II, Monday, Nov. 13 from 9-11am PST
    Abstract #1145, Poster Session B: Miscellaneous Rheumatic & Inflammatory Diseases Poster II, Monday, Nov. 13 from 9-11am PST
    Understanding Community Perspectives on Disease Management: A Social Media Analysis of Gout Care Strategies
    Abstract #1691, Oral Abstract Session: Spondyloarthritis Including Psoriatic Arthritis – Treatment II: PsA, Monday Nov. 13 from 5-5:10pm PST
    Apremilast Reduces Inflammation as Measured by MRI of the Hand in Patients With Psoriatic Arthritis: Primary Results from the Phase 4 MOSAIC Study
    Abstract #1690, Oral Abstract Session: Spondyloarthritis Including Psoriatic Arthritis – Treatment II: PsA, Monday Nov. 13 from 4:45-4:55pm PST
    Abstract #0966, Poster Session B: Epidemiology & Public Health Poster II, Monday Nov. 13 from 9-11am PST
    Abstract #1041, Poster Session B: Imaging of Rheumatic Diseases Poster I, Monday Nov. 13 from 9-11am PST
    Effect of Apremilast Treatment on the Domains of MDA-Joints in Patients With Early Oligoarticular Psoriatic Arthritis: 16-Week Results From FOREMOST
    Abstract #1413, Poster Session B: Spondyloarthritis Including Psoriatic Arthritis – Treatment Poster II: SpA, Monday Nov. 13 from 9-11am PST
    Abstract #1414, Poster Session B: Spondyloarthritis Including Psoriatic Arthritis – Treatment Poster II: SpA, Monday Nov. 13 from 9-11am PST
    Current Trends in the Risk of Subsequent Fracture After Initial Fracture, and Post-Fracture Treatment Among Commercially Insured Postmenopausal Women in the United States
    Abstract #2528, Oral Abstract Session: Osteoporosis & Metabolic Bone Disease – Basic & Clinical Science, Tuesday, Nov. 14 from 4:15-4:25pm PST
    Comparative Effectiveness of Denosumab versus Zoledronic Acid Among Postmenopausal Women with Osteoporosis in the U.S. Medicare Program
    Abstract #2529, Oral Abstract Session: Osteoporosis & Metabolic Bone Disease – Basic & Clinical Science, Tuesday, Nov. 14 from 4:30-4:40pm PST
    Comparative Effectiveness of Denosumab versus Alendronate among Postmenopausal Women with Osteoporosis in the U.S. Medicare Program
    Abstract #2008, Poster Session C: Osteoporosis & Metabolic Bone Disease – Basic & Clinical Science Poster, Tuesday, Nov. 14 from 9-11am PST
    Abstract #0683, Poster Session A: Vasculitis – ANCA-Associated Poster I: Treatment Outcomes, Sunday, Nov. 12 from 9-11am PST
    Abstract #0684, Poster Session A: Vasculitis – ANCA-Associated Poster I: Treatment Outcomes, Sunday, Nov. 12 from 9-11am PST
    Abstract #0685, Poster Session A: Vasculitis – ANCA-Associated Poster I: Treatment Outcomes, Sunday, Nov. 12 from 9-11am PST
    Abstract #0686, Poster Session A: Vasculitis – ANCA-Associated Poster I: Treatment Outcomes, Sunday, Nov. 12 from 9-11am PST
    Abstract #2379, Poster Session C: Vasculitis – ANCA-Associated Poster III: Biomarkers & Renal Outcomes, Tuesday, Nov. 14 from 9-11am PST
    Abstract #0171, Poster Session A: Health Services Research Poster I, Sunday, Nov. 12 from 9-11am PST
    Dazodalibep, a CD40L Antagonist, in Subjects with Sjögren's Having Moderate-to-Severe Systemic Disease Activity: Full Crossover Results from a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study
    Abstract #1636, Oral Abstract Session: Sjögren's Syndrome – Basic & Clinical Science, Monday, Nov. 13 from 2-3:30pm PST
    Abstract #1638, Oral Abstract Session: Sjögren's Syndrome – Basic & Clinical Science, Monday, Nov. 13 from 2-3:30pm PST
    Treatment Patterns and Drivers of Biologic Prescriptions in Patients with Primary Sjögren's Disease: Results from a Multinational, Real-World Survey
    Abstract #1369, Poster Session B: Sjögren's Syndrome – Basic & Clinical Science Poster I, Monday, Nov. 13 from 9-11am PST
    Population Pharmacokinetic/Pharmacodynamic Modeling of Dazodalibep, a CD40L Antagonist, in Healthy Volunteers and Patients with Rheumatoid Arthritis and Sjögren's Syndrome
    Abstract #1379, Poster Session B: Sjögren's Syndrome – Basic & Clinical Science Poster I, Monday, Nov. 13 from 9-11am PST
    Disease Burden of Patients with Primary Sjögren's Disease: Results from a Multinational Real-World Survey
    Abstract #2179, Poster Session C: Sjögren's Syndrome – Basic & Clinical Science Poster II, Tuesday, Nov. 14 from 9-11am PST
    Osteoporosis Treatment Attributes and Levels for an Online Decision-Making Tool for Patients: Findings from Adaptive Choice-Based Conjoint Analysis
    Abstract #0688, Poster Session A: Vasculitis – ANCA-Associated Poster I: Treatment Outcomes, Sunday, Nov. 12 from 9-11am PST

‘Dean of Asian Myeloma’ Dr. Kazuyuki Shimizu to Receive First Asian Myeloma Network (AMN) Distinguished Service Award

Retrieved on: 
Saturday, October 21, 2023
Multiple myeloma, IMF, Doctor of Philosophy, Multimodal, JSM, Executive Committee, Panobinostat, Prognosis, Physician, Global Affairs Canada, Binding site, Patient, International Myeloma Foundation, Penn State Holy Spirit, Denosumab, MD, IMS, Research, Society, Memorial Sloan Kettering Cancer Center, EMN, AMN, Government, Holy Spirit Hospital (Makeni), Shangri-La Hotel, Bangkok, Memorial, Flow cytometry, Thalidomide, Nursing, Medical device, Cryptocurrency, Blood

The Asian Myeloma Network Distinguished Service Award was conceived to recognize and honor the lifelong achievements of deserving AMN myeloma specialists, who have made a considerable impact in the field of myeloma research, clinical trials, and patient support.

Key Points: 
  • The Asian Myeloma Network Distinguished Service Award was conceived to recognize and honor the lifelong achievements of deserving AMN myeloma specialists, who have made a considerable impact in the field of myeloma research, clinical trials, and patient support.
  • “As the first awardee for the AMN’s Distinguished Service Award, Prof. Shimizu is uniquely deserving as a dedicated and accomplished clinician and myeloma researcher.
  • He greatly assisted in the establishment of the Asian Myeloma Network by ensuring robust Japanese involvement and by leading discussions about structural and strategic plans for network activities.
  • The AMN Distinguished Service Award provides a spotlight to honor leading Asian myeloma specialists,” added Mr. Navid.