Biocon Receives Health Canada Approval for Biosimilars Bosaya and Vevzuo

Biocon Receives Health Canada Approval for Biosimilars Bosaya and Vevzuo​

Biocon Limited, an innovation-led global biopharmaceutical company, has announced that Health Canada granted a Notice of Compliance (NOC) for two biosimilar products: Bosaya™ (denosumab) and Vevzuo™ (denosumab). The approval, secured on April 3, 2026, makes both biosimilars available in Canada, offering potential therapeutic benefit to an estimated two million adults suffering from osteoporosis and hundreds of patients annually facing bone metastasis from advanced cancer.

Bosaya™ and Vevzuo™ are biosimilars of Prolia® and Xgeva®, respectively. The company reported that Bosaya™ was approved in its 60 mg/mL injection prefilled syringe format, while Vevzuo™ was approved as a 120 mg/1.7 mL (70 mg/mL) single-dose vial for subcutaneous use. Denosumab products are crucial for bone health, playing a role in increasing bone mass and treating osteoporosis, alongside managing bone complications associated with cancer.

Shreehas Tambe, CEO & Managing Director of Biocon Ltd., stated that Health Canada's approval of BOSAYA and VEVZUO marks a significant milestone. He noted that this achievement expands access to high-quality biosimilars in key global markets and reinforces Biocon's commitment to patients with osteoporosis and cancer-related bone conditions.

Approved Indications​

The approval covers several critical therapeutic areas, detailed below:

Bosaya™ Indications:

• Treatment of postmenopausal women with osteoporosis at high risk for fracture.
• Increasing bone mass in men with osteoporosis at high risk for fracture.
• Increasing bone mass in men with nonmetastatic prostate cancer receiving androgen deprivation therapy (ADT), who are at high risk for fracture.
• Increasing bone mass in women with nonmetastatic breast cancer receiving adjuvant aromatase inhibitor (AI) therapy.
• Increasing bone mass in women and men at high risk for fracture due to sustained systemic glucocorticoid therapy.

Vevzuo™ Indications:

• Reducing the risk of developing skeletal-related events in patients with multiple myeloma and those with bone metastases from breast cancer, prostate cancer, non-small cell lung cancer, and other solid tumors.
• Treating giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity, in adults and skeletally mature adolescents.
• Treatment of hypercalcemia of malignancy that is refractory to intravenous bisphosphonate.

Understanding Denosumab​

Denosumab is a human monoclonal antibody that targets and binds to Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL). Since RANKL is essential for the formation, function, and survival of osteoclasts (the cells responsible for bone resorption), denosumab works by blocking RANKL, thereby reducing bone breakdown and strengthening bone mass.

Safety and Precautions​

The approval was based on analytical, nonclinical, and clinical data, demonstrating that BOSAYA and VEVZUO are highly similar to PROLIA and XGEVA, respectively, with no clinically meaningful differences in quality, safety, or efficacy.

Key warnings and precautions associated with the products include:

General Warnings:

• Monitoring of calcium is recommended before each dose.
• Clinically significant hypersensitivity reactions, including anaphylaxis, have been reported. Symptoms can include hypotension, dyspnea, throat tightness, facial and upper airway edema, pruritus, and urticaria.
• Osteonecrosis of the jaw (ONJ) may increase with the duration of exposure to denosumab.
• Atypical femoral fractures have been reported.
• Multiple vertebral fractures (MVF) may occur following discontinuation of treatment, particularly if the patient has a history of vertebral fracture.

Specific Warnings:

• Bosaya™: Hypocalcemia must be corrected by adequate intake of calcium and vitamin D before starting therapy. It is not indicated for use in pediatric patients, nor is it recommended for use in nursing women.
• Vevzuo™: Severe symptomatic hypocalcemia is a risk, which can manifest as altered mental status, tetany, seizures, and QTc prolongation. Monitoring calcium levels is required prior to the initial dose, within two weeks after the initial dose, and if hypocalcemia symptoms occur.

Biocon Ltd., headquartered in Bengaluru, India, is a global biopharmaceutical company. The company focuses on addressing pressing healthcare challenges by offering both biosimilars and generics at scale. Biocon has commercialized 12 biosimilar products and over 30 generic formulations globally, maintaining a research and development pipeline exceeding 20 biosimilar assets.

BIOCON Stock Price Movement​

Shares of Biocon Limited slipped by 0.28% on Monday, settling at ₹359.05. The stock finished trading on a volume of 1.87 million shares, closing below its previous session's weighted average price.