Celltrion USA Launches New Denosumab Biosimilars to Patients
Celltrion USA Launches Biosimilars for Better Patient Care
Celltrion USA has announced the U.S. launch of their latest biosimilars, STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo). These products have received FDA approval for all indications associated with PROLIA® (denosumab) and XGEVA® (denosumab), making them significant additions to clinical practice.
Details of the Biosimilars
STOBOCLO is a 60 mg/mL injectable formulation that addresses the needs of postmenopausal women at high fracture risk due to osteoporosis. It successfully enhances bone mass in men suffering from the same condition and provides critical treatment options for various patients including those with glucocorticoid-induced osteoporosis.
OSENVELT, offered in a 120 mg/1.7 mL injection format, plays an important role in preventing skeletal-related events among patients with multiple myeloma as well as those with bone metastases from solid tumors. Its applications extend to managing severe conditions such as hypercalcemia associated with malignancy.
Advancing Patient Support
In line with their commitment to patients, Celltrion has also introduced comprehensive support programs like the Celltrion CONNECT® Patient Support Program and the Celltrion CARES™ Co-pay Assistance Program. These initiatives aim to empower patients throughout their treatment journey, ensuring they have access to medications regardless of their financial situation.
With patient support at the forefront, Celltrion assures patients that those uninsured may receive these medications at no cost, significantly alleviating the financial burden for many.
Commitment to Quality
Celltrion's commitment to high-quality biologic medicines solidifies their position in the biosimilar market. Notably, the company has a legacy in developing therapies that significantly improve patient health and wellbeing. Their range of biosimilars extends into multiple therapeutic categories including immunology and oncology.
“We are thrilled to introduce our denosumab biosimilars to the U.S. market,” said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. “This launch allows us to provide patients and healthcare professionals with critical alternatives, further enhancing the sustainability of healthcare systems.”
Understanding Indications and Safety Information
STOBOCLO and OSENVELT have specific indications that healthcare providers must follow. For STOBOCLO, approved uses include treatments for postmenopausal women with osteoporosis and men receiving androgen deprivation therapy, among others. Meanwhile, OSENVELT serves to manage more complex conditions such as giant cell tumors of the bone and treatment-refractory hypercalcemia associated with malignancies.
It is crucial for patients with advanced kidney disease to seek guidance from healthcare providers before initiating treatment, given certain risks like severe hypocalcemia associated with the drug.
About Celltrion
Founded in 2002, Celltrion has carved out a niche in the biopharmaceutical industry by innovating in the development and manufacturing of advanced biosimilars. The company continues to expand its portfolio, adapting to the changing landscape of patient care to deliver effective therapies worldwide.
For more information, prospective users are encouraged to visit Celltrion’s websites for comprehensive details about their products and patient resources.
Frequently Asked Questions
What are STOBOCLO® and OSENVELT®?
STOBOCLO and OSENVELT are denosumab biosimilars that provide effective treatment options for specific bone health issues.
Who can benefit from these biosimilars?
Patients with osteoporosis, multiple myeloma, and bone metastases can benefit from these therapies, enhancing their quality of care.
How do the patient support programs work?
Celltrion’s support programs aid patients in accessing their medications, even if uninsured, ensuring no one is left without treatment.
Are there any specific safety concerns?
Patients with advanced kidney disease need careful monitoring when using STOBOCLO due to risks of severe hypocalcemia.
What is Celltrion's commitment to innovation?
Celltrion is dedicated to advancing biopharmaceutical innovations, developing therapies that improve health outcomes across various therapeutic areas.
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