Biocon Shares Jump 3% on USFDA Approval for Two Biosimilars

The US Food and Drug Administration’s approval of Biocon Biologics’ two denosumab biosimilars represents a major regulatory achievement for the Indian biopharmaceutical giant. Bosaya, a biosimilar of Amgen’s Prolia, and Aukelso, a biosimilar of Xgeva, both received not only approval but also provisional interchangeability status. This designation is particularly significant as it allows pharmacists to substitute these biosimilars for the reference products under certain conditions, potentially accelerating market adoption and penetration in the United States.

Investors responded enthusiastically to the news, driving Biocon’s share price up 3.07% to Rs 365.25 on the National Stock Exchange (NSE). This positive market reaction reflects confidence in Biocon’s ability to capitalize on these approvals in the lucrative US biologics market. The company’s stock had been trading 2% higher earlier in the session before settling at the 3% gain, indicating sustained investor interest throughout the trading day.

Bosaya’s approval covers multiple osteoporosis indications, positioning it as a comprehensive treatment option for patients at high fracture risk. The biosimilar is approved for postmenopausal women with osteoporosis, men with osteoporosis at high fracture risk, and patients with glucocorticoid-induced osteoporosis. Additionally, it addresses bone loss concerns in specific cancer patient populations—men receiving androgen deprivation therapy for non-metastatic prostate cancer and women receiving adjuvant aromatase inhibitor therapy for breast cancer.

Aukelso targets more severe bone-related conditions, particularly in oncology care. Its approvals include preventing skeletal-related events in patients with multiple myeloma or bone metastases from solid tumors, treating giant cell tumors of bone in adults and skeletally mature adolescents where surgery isn’t feasible, and managing bisphosphonate-resistant cancer-related hypercalcemia. This broad indication spectrum significantly expands Biocon’s oncology portfolio and addresses unmet needs in cancer supportive care.

Shreehas Tambe, CEO and Managing Director of Biocon Biologics, emphasized the strategic importance of these approvals, stating they represent “a significant milestone in our mission to expand access to critical biologic therapies.” He highlighted the dual benefit of offering more affordable treatment options for osteoporosis patients while simultaneously expanding the company’s oncology care portfolio. This achievement underscores Biocon’s scientific and regulatory capabilities in the competitive biosimilars space.

The approvals reinforce Biocon’s commitment to delivering high-quality biosimilars that support sustainable healthcare systems while improving patient outcomes. The provisional interchangeability status particularly enhances the commercial potential of both products, as it may facilitate faster market uptake and potentially larger market share in the US biologics market. This development positions Biocon Biologics more strongly against established competitors in the denosumab market space.

For investors tracking the NSE, this regulatory success demonstrates Biocon’s continued execution capability in navigating complex USFDA approval processes. The market’s positive response suggests expectations of meaningful revenue contribution from these biosimilars once launched, potentially strengthening Biocon’s position in the global biologics market and validating the company’s research and development investments in biosimilar products.