Abbott Receives Approval For Two New Biosimilars In Brazil, Expanding Access To Treatment For Osteoporosis And Bone Complications Related To Cancer

• These new approvals expand Abbott's offering of biological and biosimilar medicines in Brazil in important therapeutic areas, including oncology, immunology, and women's health.
• The newly approved denosumab biosimilars offer more treatment access options for millions of Brazilians living with osteoporosis and cancer-related bone complications.

São Paulo /PRNewswire/ - Abbott (NYSE: ABT), a global leader in healthcare, has just received regulatory approval from Anvisa (Brazilian Health Regulatory Agency) for two new denosumab biosimilar medications in Brazil (60 mg and 120 mg), representing another significant step in expanding access to advanced therapies for osteoporosis and cancer-related bone complications. With this, the denosumab biosimilars marketed by Abbott make advanced biological treatment even more accessible to the approximately 10 million Brazilians affected by these conditions .

"For people living with osteoporosis or cancer-related bone complications, access to denosumab biosimilar options can truly be life-changing," says Dr. Mauricio Morales Castillo, Global Associate Medical Director for pharmaceuticals at Abbott. "With these approvals, Brazilians affected by these conditions now have greater access to this transformative therapy."

Facing a growing challenge in the health field
, osteoporosis, a chronic age-related disease, is a serious public health problem. The condition has a significant and often debilitating impact, including fractures that lead to loss of independence and reduced quality of life. ²

According to the International Osteoporosis Foundation, approximately 10 million people in Brazil suffer from the disease. ¹ As the population ages—with projections indicating that 25% of people will be 60 years or older in the next decade—a sharp increase in the number of fractures, disabilities, and healthcare costs related to osteoporosis is expected. ²

Furthermore, it is one of the leading causes of mortality among the elderly and particularly affects postmenopausal women. The Phase III SIMBA study, conducted by mAbxience and published in the journal Pharmaceutics (2026), confirmed that the biosimilar MB09 marketed by Abbott has similar efficacy and safety to the reference biological drug, offering equivalent protection against bone loss in postmenopausal women. ³

Abbott will provide denosumab as part of its broader strategy to expand access to high-quality medicines in key therapeutic areas, including oncology, immunology, and women's health, through relevant partnerships with biotechnology companies.

"These regulatory approvals strengthen Abbott's portfolio in Brazil and represent a decisive step in the fight against osteoporosis, a chronic condition that highlights the challenges of an aging population. The approvals expand the treatment options available to patients, promoting mobility, autonomy, and quality of life. This reflects Abbott's ongoing commitment to meeting constantly evolving health needs through high-quality therapies," concludes Dr. Castillo.

With nearly 90 years of presence in Brazil and over 135 years of global history offering transformative healthcare solutions, Abbott reaffirms its commitment to helping people live their best lives at every stage of life. The arrival of these denosumab options aims to expand access to quality treatments and reinforce the company's role in combating chronic diseases in the country.

About mAbxience and the Collaboration
These denosumab biosimilars were developed and produced by mAbxience, which is also responsible for the Phase III SIMBA study. This is the result of a strategic cooperation agreement signed between mAbxience and Abbott in 2023, under which mAbxience develops, produces, and supplies the biosimilars, while Abbott registers and markets them in key emerging markets in Latin America, Southeast Asia, the Middle East, and Africa.

About Abbott
Abbott is a leading global healthcare company that helps people live life to the fullest at every stage of life. Our portfolio of life-changing technologies spans the entire healthcare spectrum through leading products and businesses in diagnostics, medical devices, nutrition and branded pharmaceuticals. Our 122,000 employees work to help people in more than 160 countries.

Present in Brazil for almost 90 years, its local strategy aims to provide people with better access to innovative medical and health solutions, contributing to the development of healthcare in the country. In Brazil, the company employs approximately 2,800 people, and its main units are located in São Paulo (administrative headquarters), Rio de Janeiro, and Belo Horizonte, where the company's two production plants are located.

Visit abbottbrasil.com.br and stay in touch via LinkedIn , Facebook , Instagram , X , and YouTube .

¹ Brazilian Society of Rheumatology. World Osteoporosis Day aims to raise awareness for disease prevention [Internet]. São Paulo: Brazilian Society of Rheumatology; 2025 [cited 2026 May 4]. Available from: https://www.reumatologia.org.br/press-releases/dia-mundial-da-osteoporose-visa-conscientizar-para-prevencao-da-doenca/https://www.reumatologia.org.br/press-releases/dia-mundial-da-osteoporose-visa-conscientizar-para-prevencao-da-doenca/
² Ministry of Health. Secretariat of Specialized Health Care. Department of Management and Incorporation of Technologies and Innovation in Health. Clinical Protocol and Therapeutic Guidelines for Osteoporosis [Internet]. Brasília: Ministry of Health; 2026 [cited 2026 May 4]. Available at: https://www.gov.br/saude/pt-br/assuntos/pcdt/o/osteoporose
³ Sharma A, Gupta R, Singh S, et al. SIMBA Study: Phase III clinical trial comparing MB09, a denosumab biosimilar, with reference denosumab in postmenopausal women with osteoporosis. Pharmaceutics. 2026;18(3):291. doi:10.3390/pharmaceutics18030291. Available at: https://www.mdpi.com/1999-4923/18/3/291 .

RESYNIV® 60 MG/ML (DENOSUMAB). MS: 1.0553.0403. ADULT USE. SUBCUTANEOUS ROUTE. INDICATIONS: Resyniv is indicated for postmenopausal women with osteoporosis; bone loss in cancer patients undergoing hormone suppression therapy; osteoporosis in men and corticosteroid-induced osteoporosis. CONTRAINDICATIONS: Contraindicated in patients with hypokalemia and hypersensitivity to any substance in Resyniv. WARNINGS AND PRECAUTIONS: Calcium and Vitamin D intake; monitoring of calcium and vitamin D; risk of osteonecrosis of the jaw. Use during pregnancy: RESYNIV® is not recommended for use in pregnant women. Category B. DRUG INTERACTIONS: Not reported. ADVERSE REACTIONS: Musculoskeletal pain and pain in the extremities. DOSAGE: 60 mg administered once every 6 months.
SOLD BY PRESCRIPTION ONLY. Imported and Registered by: Abbott Laboratories of Brazil Ltda. MB 01 (BU01).
DNOCLAST® 120 MG/1.7 ML (DENOSUMAB). MS: 1.0553.0402. FOR ADULT AND PEDIATRIC USE OVER 12 YEARS ^OF AGE. SUBCUTANEOUS ROUTE. INDICATIONS: Prevention of skeletal events related to Multiple Myeloma, bone metastasis of solid tumors and adult giant cell tumors; Hypercalcemia of malignancy. CONTRAINDICATIONS: Severe hypocalcemia and hypersensitivity to the drug. WARNINGS AND PRECAUTIONS: Calcium and Vitamin D intake; Calcium and Vitamin D monitoring; Risk of Osteonecrosis of the Jaw. Use during pregnancy: Dnoclast® is not recommended for use in pregnant women. Category C. DRUG INTERACTIONS: Not reported. ADVERSE REACTIONS: Musculoskeletal pain and pain in the extremities. DOSAGE: 120 mg once every 4 weeks. SOLD BY PRESCRIPTION ONLY. Imported and Registered by: Abbott Laboratories of Brazil Ltda. MB 01 (BU01).