Biologics

Celltrion’s Prolia and Xgeva Biosimilars Approved

FDA has approved a Celltrion BLA for Stoboclo (denosumab-bmwo), a biosimilar to Amgen’s Prolia, and Osenvelt (denosumab-bmwo), a biosimilar to Amgen’s Xgeva. The approval covers all indications of the reference products.

Approval is based on “robust clinical evidence,” including data from Phase 3 clinical trials in postmenopausal women with osteoporosis that were designed to evaluate the efficacy, pharmacodynamics, pharmacokinetics, safety and immunogenicity of the biosimilars to reference denosumab, Celltrion says

Stoboclo is approved to treat postmenopausal women with osteoporosis who are at high risk for fracture, to increase bone mass in men with osteoporosis, to treat glucocorticoid-induced osteoporosis in men and women, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer, according to Celltrion.

Osenvelt is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat patients with giant cell tumor of the bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia, according to the company.

Celltrion says the products will launch in June under a settlement agreement with Amgen.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome