Biocon Launches Denosumab Biosimilars

Published: 2026-04-29 04:10:12 ET AMGN

Published on 04/29/2026 at 04:10 am EDT

On April 7, 2026, Biocon Limited announced that it had launched BOSAYA (denosumab-kyqq) and AUKELSO (denosumab-kyqq) in the United States. Both products are RANK ligand inhibitors used to treat conditions such as osteoporosis and cancer-related skeletal complications. BOSAYA and AUKELSO have been designated as interchangeable with their corresponding reference products, Amgen's PROLIA® and XGEVA®, respectively.

Biocon estimates that tens of millions of adults in the United States are at risk for the conditions treated by denosumab. In 2024 alone, the denosumab market represented approximately $5 billion in U.S. pharmaceutical sales. According to Biocon, this data reflects the growing need for accessible treatment options, which Biocon hopes to address through its denosumab biosimilars.

The commercial launch comes less than a year after Amgen and Biocon settled BPCIA litigation in the U.S. District Court for the District of New Jersey. In that litigation, Amgen asserted 34 patents against Biocon's denosumab biosimilars. As part of the settlement, the parties agreed that Biocon could launch its biosimilars as early as October 1, 2025.

Biocon joins Sandoz, Celltrion, Fresenius, and Hikma/Gedeon in launching denosumab biosimilar products in the United States.

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Timothy Beavers Goodwin Procter LLP The New York Times Building 620 Eighth Avenue New York NY 10018 UNITED STATES Tel: 212813 8800 E-mail: [email protected] URL: www.goodwinlaw.com