Osteoporosis, Postmenopausal

TORONTO--(BUSINESS WIRE)--Celltrion today announced that Health Canada has approved Stoboclo® and Osenvelt® (CT-P41), biosimilars referencing Prolia® and Xgeva®, respectively for all indications of reference products.1,2 “The approval of Stoboclo and Osenvelt underscores our commitment to developing patient-centric therapies, particularly for incurable forms of disease such as osteoporosis where patients face difficult prognoses,” said Jungyong Shin, Managing Director at Celltrion Healthcare Canada. “We are proud to lead the biosimilar industry with our expanded portfolio, offering significant cost-saving potential while enhancing patient access and supporting the Canadian skeletal disorders community.” The Health Canada approval is based on robust clinical evidence, including results from a Phase III clinical trial in postmenopausal women with osteoporosis designed to evaluate the efficacy, pharmacodynamics (PD), pharmacokinetics (PK), safety and immunogenicity of CT-P41 to reference denosumab. Study results demonstrated that CT-P41 had equivalent efficacy and pharmacodynamics to reference denosumab with similar pharmacokinetics and comparable safety and immunogenicity profiles.3 Stoboclo and Osenvelt are Celltrion’s sixth biosimilars approved in Canada after receiving the company’s approval of Remdantry™/ Remsima® SC (infliximab), Yuflyma® (adalimumab), Vegzelma® (bevacizumab), SteQeyma® (ustekinumab), Omlyclo® (omalizumab). Notes to Editors: About Stoboclo® Stoboclo® is a receptor activator of NF-κb ligand (RANKL) inhibitor (bone metabolism regulator) developed as a biosimilar referencing Prolia® (denosumab) approved in Canada. Stoboclo has been approved for indications approved for the reference products, Prolia. Denosumab biosimilars and reference product (Prolia) have been approved in Canada to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to increase bone mass in men with nonmetastatic prostate cancer receiving androgen deprivation therapy (ADT), to increase bone mass in women with nonmetastatic breast cancer receiving adjuvant aromatase inhibitor (AI) therapy, and to increase bone mass for the treatment and prevention of glucocorticoid-induced osteoporosis in women and men at high risk for fracture. Stoboclo is available as 60 mg / mL solution for injection in prefilled syringe.1 About Osenvelt® Osenvelt® is a receptor activator of NF-κb ligand (RANKL) inhibitor (bone metabolism regulator) developed as a biosimilar referencing Xgeva® (denosumab) approved in Canada. Osenvelt has been approved for indications approved for the reference products, Xgeva. Denosumab biosimilars and reference product (Xgeva) are indicated to reduce the risk of developing skeletal-related events in patients with multiple myeloma and in patients with bone metastases from breast cancer, prostate cancer, non-small cell lung cancer, and other solid tumours, to treat adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy that is refractory to intravenous bisphosphonate. Osenvelt is available as 120 mg/1.7 mL solution for injection in single-use vial.2 About Celltrion Inc. Celltrion is a leading biopharmaceutical company that specialises in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, haematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook. About Celltrion Healthcare Canada Limited Celltrion Healthcare Canada is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with Health Canada regulations. With the approval of Stoboclo® and Osenvelt®, Celltrion now has eight products across six biosimilars approved by Health Canada: Remdantry™/ Remsima® SC (infliximab), Yuflyma® (adalimumab), Vegzelma® (bevacizumab), SteQeyma® (ustekinumab), Omlyclo® (omalizumab), Stoboclo® and Osenvelt® (denosumab). For more information, please visit: https://www.celltrionhealthcare.ca Stoboclo® and Osenvelt® are trademarks of Celltrion, Inc. and are used under license. Prolia® and Xgeva® are registered trademarks of Amgen Inc. ____________________ 1 Stoboclo Product Monograph. Celltrion Inc. September 2025. Product information from Health Canada. 2 Osenvelt Product Monograph. Celltrion Inc. September 2025. Product information from Health Canada. 3 Reginster JY et al. Efficacy and safety of candidate biosimilar CT-P41 versus reference denosumab: a double-blind, randomized, active-controlled, Phase 3 trial in postmenopausal women with osteoporosis. Osteoporos Int. 2024 Nov;35(11):1919-1930. doi: 10.1007/s00198-024-07161-x. Epub 2024 Jul 23. PMID: 39042292; PMCID: PMC11499533. Available at: https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/39042292/ [Last accessed September 2025].

BENGALURU, India and BRIDGEWATER, N.J., Sept. 17, 2025 /PRNewswire/ -- Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE: 532523, NSE: BIOCON), today announced that the U.S. Food and Drug Administration (FDA) has approved Bosaya™ (denosumab-kyqq) 60 mg/mL injection for subcutaneous use in a single dose prefilled syringe (PFS), and Aukelso™ (denosumab-kyqq) 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial, biosimilars of Prolia® and Xgeva® respectively. In addition, the U.S. FDA granted provisional interchangeability designation for both BOSAYA and AUKELSO. Shreehas Tambe, CEO & Managing Director, Biocon Biologics, said, "The FDA's approval of Bosaya™ and Aukelso™ is a significant milestone in our mission to expand access to critical biologic therapies. With Bosaya™, we are proud to offer a more affordable treatment option for patients with osteoporosis, and with Aukelso™, we are further expanding our oncology care portfolio. This achievement underscores our scientific and regulatory capabilities and reinforces our commitment to delivering high-quality biosimilars that support sustainable healthcare systems and improve patient outcomes." BOSAYA is approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, glucocorticoid-induced osteoporosis in men and women at high risk for fracture, 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. AUKELSO is approved for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy. Clinical data showed that both biosimilars demonstrated comparable quality, safety, and efficacy to the reference product. BOSAYA is approved with the same Risk Evaluation and Mitigation Strategy (REMS) plan as PROLIA to likewise inform healthcare providers and patients of the risks of severe hypocalcemia in patients with advanced chronic kidney disease (CKD), including dialysis-dependent patients, associated with BOSAYA. According to IQVIA National Sales Perspectives Data, denosumab had nearly $5 billion in U.S. sales for the period ending December 2024, with PROLIA achieving $3.3 billion and XGEVA generating $1.6 billion. Epidemiology: Osteoporosis is a chronic disease that weakens bones, making them fragile and more prone to fracture. In the U.S., approximately 10 million adults over age 50 are estimated to have osteoporosis, with another 44 million at risk due to low bone density.1,2 One in two women and up to one in four men over age 50 will break a bone in their lifetime due to osteoporosis.3 Bone metastases are a common complication of advanced cancer, affecting more than 330,000 patients annually in the United States.4 Skeletal complications can significantly impair quality of life and increase healthcare burden.5 Giant cell tumor of bone (GCTB) is a rare, locally aggressive benign tumor that primarily affects young adults. While noncancerous, it can cause severe pain, fractures, and disability. About BOSAYA and AUKELSO: Denosumab is a human monoclonal antibody that targets and binds to Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL). RANKL is essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. By blocking RANKL, denosumab reduces bone breakdown, increasing bone mass and strength. About BOSAYA (denosumab-kyqq) Warnings and Precautions: Pre-existing hypocalcemia must be corrected before initiating BOSAYA. May worsen, especially in patients with renal impairment. Adequately supplement all patients with calcium and vitamin D. Concomitant use of calcimimetic drugs may also worsen hypocalcemia risk. Evaluate for presence of chronic kidney disease mineral-bone disorder. Monitor serum calcium. Patients receiving BOSAYA should not receive other denosumab products concomitantly. Hypersensitivity including anaphylactic reactions may occur. Discontinue permanently if a clinically significant reaction occurs. Osteonecrosis of the jaw has been reported with denosumab products. Monitor for symptoms. Atypical femoral fractures: Have been reported. Evaluate patients with thigh or groin pain to rule out a femoral fracture. Multiple vertebral fractures have been reported following treatment discontinuation. Patients should be transitioned to another antiresorptive agent if BOSAYA is discontinued. Serious infections including skin infections may occur, including those leading to hospitalization. Advise patients to seek prompt medical attention if they develop signs or symptoms of infection, including cellulitis. Dermatologic reactions such as, dermatitis, rashes, and eczema have been reported. Consider discontinuing BOSAYA if severe symptoms develop. Severe bone, joint, muscle pain may occur. Discontinue use if severe symptoms develop. Significant suppression of bone turnover has been demonstrated. Monitor for consequences of bone over-suppression. Adverse reactions: Postmenopausal osteoporosis: Most common adverse reactions (> 5% and more common than placebo) were: back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, and cystitis. Pancreatitis has been reported in clinical trials. Male osteoporosis: Most common adverse reactions (> 5% and more common than placebo) were: back pain, arthralgia, and nasopharyngitis. Glucocorticoid-induced osteoporosis: Most common adverse reactions (> 3% and more common than active-control group) were: back pain, hypertension, bronchitis, and headache. Bone loss due to hormone ablation for cancer: Most common adverse reactions (≥ 10% and more common than placebo) were: arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials. Use in Specific Populations: Pregnant women and females of reproductive potential: Denosumab products may cause fetal harm when administered to pregnant women. Advise females of reproductive potential to use effective contraception during therapy, and for at least 5 months after the last dose of BOSAYA. Pediatric patients: BOSAYA is not approved for use in pediatric patients. Renal impairment: No dose adjustment is necessary in patients with renal impairment. Patients with advanced chronic kidney disease (eGFR<30 mL/min/1.73 m2), including dialysis-dependent patients, are at greater risk of severe hypocalcemia. The presence of underlying chronic kidney disease-mineral bone disorder markedly increases the risk of hypocalcemia. About AUKELSO (denosumab-kyqq) Warnings and Precautions: Patients receiving AUKELSO should not receive other denosumab products concomitantly. Hypersensitivity reactions including anaphylaxis may occur. Discontinue permanently if a clinically significant reaction occurs. Denosumab products can cause severe symptomatic hypocalcemia. Fatal cases have been reported with denosumab products use. Correct hypocalcemia prior to initiating AUKELSO. Monitor calcium levels during therapy, especially in the first weeks of initiating therapy, and adequately supplement all patients with calcium and vitamin D. Osteonecrosis of the jaw (ONJ) has been reported in patients receiving denosumab products. Perform an oral examination prior to starting AUKELSO. Monitor for symptoms. Avoid invasive dental procedures during treatment with AUKELSO. Evaluate patients with thigh or groin pain to rule out a femoral fracture. Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone and in Patients with Growing Skeletons, patients should be monitored for signs and symptoms of hypercalcemia, and manage as clinically appropriate. Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation, when AUKELSO treatment is discontinued, evaluate the individual patient's risk for vertebral fractures. Embryo-Fetal Toxicity can cause fetal harm. Advise females of reproductive potential of potential risk to the fetus and to use effective contraception. Adverse Reactions: Bone Metastasis from Solid Tumors: Most common adverse reactions (≥ 25%) were fatigue/asthenia, hypophosphatemia, and nausea. Multiple Myeloma: Most common adverse reactions (≥ 10%) were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache. Giant Cell Tumor of Bone: Most common adverse reactions (≥ 10%) were arthralgia, headache, nausea, back pain, fatigue, and pain in extremity. Hypercalcemia of Malignancy: Most common adverse reactions (> 20%) were nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea. Use in Specific Populations: Pediatric patients: Recommended only for treatment of skeletally mature adolescents with giant cell tumor of bone. Renal impairment: Patients with creatinine clearance less than 30 mL/min or receiving dialysis are at risk for hypocalcemia. Adequately supplement with calcium and vitamin D. Please refer to the full Patient Information for detailed safety information. To report SUSPECTED ADVERSE REACTIONS, contact Biocon Biologics at 1-833-986-1468. Bosaya™ and Aukelso™ are trademarks of Biocon Biologics Limited. BIOCON BIOLOGICS and the Biocon Biologics Logo are registered trademarks of Biocon Biologics Limited. All other trademarks are the property of their respective owners. 1 Bone Health and Osteoporosis Foundation. "Osteoporosis Fast Facts." Accessed: September 14, 2025. 2 American Medical Association. "What doctors wish patients knew about osteoporosis." Accessed: September 14, 2025. Published: May 3, 2024. 3 Hernandez RK, Adhia A, Wade SW, O'Connor E, Arellano J, Francis K, Alvrtsyan H, Million RP, Liede A. Prevalence of bone metastases and bone-targeting agent use among solid tumor patients in the United States. Clin Epidemiol. 2015 Jul 17;7:335-45. 4 Moffitt Cancer Center. "Bone Metastasis." Accessed: September 14, 2025. 5 American Cancer Center. "Bone Metastases." Accessed: September 14, 2025. About Biocon Biologics Limited: Biocon Biologics Limited, a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives. It is capitalizing on its 'lab to market' capabilities to serve over 6.0 million patients across 120+ countries by enabling affordable access to high quality biosimilars. The Company is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes. Biocon Biologics has commercialized 10 biosimilars from its portfolio which are addressing the patients' needs in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It has a pipeline of 20 biosimilar assets across diabetology, oncology, immunology, ophthalmology, bone health and other non-communicable diseases. The Company has many 'firsts' to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, it is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). The meaningful progress on ESG parameters has been recognized with the Company's inclusion in the S&P Global Sustainability Yearbook in 2025. Website: ; Follow us on X (formerly Twitter): @BioconBiologics and LinkedIn: Biocon Biologics for company updates. Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: ; Follow-us on X (formerly Twitter) @bioconlimited and LinkedIn: Biocon for company updates. Forward-Looking Statements: Biocon This press release may include statements of future expectations and other forward-looking statements based on management's current expectations and beliefs concerning future developments and their potential effects upon Biocon and its subsidiaries/ associates. These forward-looking statements involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from our expectations include, amongst other: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or any of our subsidiaries/associates assume any obligation to update any particular forward-looking statement contained in this release. 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July 28, 2025 -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptides and protein replacement therapies, announced today that in a written response to a Type A meeting request, the U.S. Food and Drug Administration (FDA) agreed with the Company’s proposal that the NDA marketing application filing for EB613 would be supported by a single multinational, randomized, double-blind, placebo-controlled, 24 month phase 3 study in women with postmenopausal osteoporosis, where change in total hip BMD is evaluated as the primary endpoint, and incidence of new or worsening vertebral fractures is evaluated as the key secondary endpoint. This marks a shift from precedent placebo-controlled phase 3 studies of new osteoporosis drugs which required incidence of fracture as the primary endpoint. “This regulatory update is a major milestone for Entera and the entire osteoporosis community,” said Miranda Toledano, CEO of Entera. “Our alignment with the FDA reflects the strength of our data and collaborative discussions. Importantly, it allows us to advance our clinical development program without having to wait for FDA’s qualification of the Study to Advance Bone Mineral Density as a Regulatory Endpoint (SABRE), which is still expected this year. We thank the FDA and the Review Team at the Division of Endocrinology for their constructive approach. We also thank the SABRE team for paving the path to innovation for osteoporosis treatment,” said Toledano. “Osteoporosis afflicts more women than heart attack, stroke and breast cancer combined. Over 200 million women globally are estimated to have osteoporosis and remain vastly undertreated, despite efficacious injectable anabolic (bone forming) treatments. One in two women over the age of 50 will suffer a fracture due to osteoporosis. No new drug for osteoporosis has been approved by FDA since 2019; and innovation has stalled for close to a decade due to the size, duration, cost and ethical constraints associated with fracture endpoint studies. In a silent disease, patient and clinician access to novel and alternative forms of validated mechanisms of action is important. We are developing EB613 as the first oral, once-daily anabolic tablet treatment to potentially serve this unmet medical need. EB613 is intended to increase skeletal mass, improve bone microarchitecture and reduce the risk of fracture,” said Miranda Toledano, CEO of Entera. Substantial evidence supports the efficacy of anabolic therapies over bisphosphonates for lowering fracture risk in osteoporosis patients at high risk. However, all available anabolic therapies are administered by subcutaneous (SC) injection and used in a minority of eligible patients. EB613 (oral PTH (1-34), teriparatide), is being developed as the first oral, once-daily anabolic tablet treatment for osteoporosis. EB613 completed a phase 2, 6-month, 161-patient, placebo-controlled study that met all biomarker and BMD endpoints without significant safety concerns in women with postmenopausal osteoporosis or low BMD (JBMR 2024). EB613 produced rapid dose-proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increased lumbar spine, total hip, and femoral neck BMD. The effects of EB613 on trabecular and cortical bone using 3D-DXA showed increases with EB613 compared with placebo in a variety of indices, including integral volumetric BMD and trabecular volumetric BMD, cortical thickness, and cortical surface BMD. Mechanistically, the findings suggest that bone strengthening, and fracture resistance may occur rapidly with EB613. Furthermore, the data are consistent with those of published subcutaneous teriparatide at the 6-month time point. Further abstracts have been submitted to ASBMR and NAMS 2025 conferences. Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N-Tab™) and its pipeline of first-in-class oral peptide programs targeting PTH(1-34), GLP-1 and GLP-2. The Company’s most advanced product candidate, EB613 (oral PTH(1-34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis. A placebo-controlled, dose-ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). The EB612 program is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity and metabolic syndromes; and first oral GLP-2 peptide as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. The Study to Advance BMD as a Regulatory Endpoint (SABRE) initiative, which started as a public private partnership sponsored by the FNIH in 2013, has amassed the strongest evidence to date that treatment-related gains in Bone Mineral Density (BMD) reliably and quantitatively predict fracture-risk reduction. In November 2023, the SABRE team submitted a full qualification package to FDA’s Biomarker Division as part of the Drug Development Tool Biomarker Qualification Pathway to potentially qualify BMD as a surrogate endpoint to fracture; in March 2024, the FDA Biomarker Division indicated to the SABRE project team that a decision would be issued within 10 months. The single most important predictor of osteoporotic fractures in postmenopausal women without a previous fracture is BMD. Treatment guidelines in the U.S. strongly recommend pharmacologic therapy for patients with a BMD T-score of -2.5 or lower in the spine, femoral neck, total hip. SABRE final FQP meta-analysis included data from 22 randomized, placebo-controlled trials (63,000 participants across seven drug classes) and showed that treatment-related gains in total-hip BMD explain 72% of the observed fracture-risk reduction. The R2 for this correlation was 0.73—double the correlation between blood pressure and stroke (R² = 0.37), which is the well accepted basis for the value of antihypertensive therapy. The content above comes from the network. if any infringement, please contact us to modify.