The pact clears the way for the U.S. launch of denosumab biosimilars Bosaya and Aukelso from 1 October 2025.
The agreement settles ongoing patent litigation in the U.S. District Court of New Jersey. It allows Biocon Biologics to market biosimilars to Amgen’s Prolia (osteoporosis) and Xgeva (cancer bone disease).
The FDA approved both drugs in September 2025 and granted them provisional interchangeability.
CEO Shreehas Tambe said the settlement expands Biocon's oncology portfolio and marks its entry into bone health. He added the launch will widen patient access to advanced biologics and strengthen Biocon’s role as a global biosimilar leader.
Biocon is a global biopharma company dedicated to improving affordable access to therapies for chronic conditions such as diabetes, cancer, and autoimmune diseases.
In its latest financial results, Biocon reported a 95.2% decline in consolidated net profit to Rs 31.40 crore despite a 15.8% jump in net sales to Rs 3,910.10 crore in Q1 FY26 compared to Q1 FY25.