US FDA approvved Biocon Biologics Denosumab Biosimilars
Biocon Biologics Ltd. (BBL), the biosimilars arm of Biocon Ltd., has announced a major regulatory milestone: the U.S. FDA has approved its denosumab biosimilars Bosaya™ and Aukelso™, with provisional interchangeability designation. These are biosimilar versions of Amgen’s blockbuster drugs Prolia® (for osteoporosis) and Xgeva® (for cancer-related bone complications).
Why This Matters
🦴 Bosaya™ will provide a more affordable treatment option for osteoporosis, a condition affecting over 10 million Americans over 50, with millions more at risk. It is approved for:
- Postmenopausal women & men with osteoporosis at high risk of fracture
- Glucocorticoid-induced osteoporosis
- Patients with prostate or breast cancer therapies that weaken bones
🎗️ Aukelso™ expands Biocon Biologics’ oncology portfolio, with approvals for:
- Preventing skeletal complications in cancer patients with bone metastases or multiple myeloma
- Treating giant cell tumor of bone (when surgery isn’t an option)
- Treating hypercalcemia of malignancy resistant to standard therapies
With Prolia® and Xgeva® generating nearly $5 billion in U.S. sales in 2024, this marks a strong entry into a high-value therapeutic area for Biocon Biologics.
What Experts Are Saying
“The FDA’s approval of Bosaya™ and Aukelso™ is a significant milestone in our mission to expand access to critical biologic therapies. This underscores our scientific and regulatory capabilities and commitment to delivering high-quality biosimilars.”
— Shreehas Tambe, CEO & MD, Biocon Biologics
Biocon Biologics founder Kiran Mazumdar-Shaw also hailed the news, noting the importance of interchangeability designation, which allows pharmacists in the U.S. (subject to state laws) to substitute the biosimilar for its reference product without prescriber intervention — improving patient access.
The Science Behind Denosumab
Denosumab is a monoclonal antibody that targets RANKL, a key protein driving bone resorption. By blocking RANKL, denosumab reduces bone breakdown, strengthens bones, and helps prevent fractures and skeletal complications.
Both Bosaya™ and Aukelso™ have shown comparable safety, quality, and efficacy to their reference products in clinical data. However, like all denosumab therapies, they carry risks such as hypocalcemia (low calcium levels), osteonecrosis of the jaw, and atypical fractures, requiring close monitoring by healthcare providers.
Looking Ahead
The FDA’s approval positions Biocon Biologics as a major global player in the high-value osteoporosis and oncology biologics markets. More importantly, it opens the door to affordable access for patients in the U.S. and, eventually, worldwide.
🔗 Read the full Biocon announcement here
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