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Biocon Biologics Sets US Entry Date for Denosumab Biosimilars

Synopsis:


Biocon Biologics signs a settlement with Amgen, enabling the US launch of its denosumab biosimilars Bosaya and Aukelso from October 1, 2025. Both products treat osteoporosis and cancer-related bone conditions and have FDA approval and provisional interchangeability status.


Source:
Biocon Limited Press Release (NSE Exchange Fillings) | Published on Oct 01, 2025

Disclaimer: This content has been published for informational purposes only. Bajaj Broking is not affiliated with, nor does it endorse or assume any responsibility for, the source material. Readers are advised to consult the original publication for complete and accurate context.

Biocon Limited News Today

As quoted in the press release of Biocon Limited (NSE Exchange Filings), Biocon Biologics, a unit of Biocon Ltd., has finalized a settlement and license agreement with Amgen Inc. which allows for the commercialisation of its denosumab biosimilars, Bosaya™ and Aukelso™, in the United States, which is anticipated to commence on October 1, 2025. Bosaya™ and Aukelso™ are biosimilars developed from Amgen’s Prolia® and Xgeva®, and are intended for the treatment of osteoporosis and cancer-related bone conditions. 

The settlement puts an end to patent litigation pending in United States District Court for the District of New Jersey, clearing the way for Biocon Biologics to enter the high-value biologics space in the United States, representing an important step in the company’s global biosimilars strategy.

Also read: Lupin secures US FDA approval for Rivaroxaban oral suspension

BIOCON LIMITED.

Trade

386.354.60 (1.20 %)

Updated - 12 December 2025
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Key Takeaways

  • Biocon Biologics to launch Bosaya and Aukelso biosimilars in the US from October 1, 2025.

  • Both are biosimilars of Amgen’s Prolia and Xgeva, used for bone-related conditions.

  • FDA approved both products in September 2025, granting provisional interchangeability.

  • Bosaya targets osteoporosis treatment in high-risk patients.

  • Aukelso is indicated for cancer-related skeletal conditions and hypercalcemia management.

Also read: Swan Defence partners with Samsung for shipbuilding collaboration

Focus Of The Settlement And FDA Approval

The Biocon Biologics-Amgen accord resolves patent disputes while ensuring Biocon Biologics is authorized to introduce its biosimilars in the US. Biocon's products include the Bosaya™ 60 mg/mL injection (PFS), and Aukelso™ 120 mg/1.7 mL injection, both of which have multiple approved indications to improve treatment access to patients.

Product

Reference

Indications

Dosage

Bosaya™

Prolia®

Osteoporosis in high-risk patients, bone mass increase, glucocorticoid-induced osteoporosis

60 mg/mL (PFS)

Aukelso™

Xgeva®

Prevention of skeletal events in multiple myeloma, treatment of bone metastases, giant cell tumour, refractory hypercalcemia

120 mg/1.7 mL

Clinical And Market Significance

Bosaya and Aukelso fulfill important medical needs. Bosaya has an indication for use in postmenopausal women and men with osteoporosis at high fracture risk, as well as patients receiving treatment for specific cancers that increase fracture risk. Aukelso provides treatment for bone metastases, giant cell tumour of the bone, and treatment-resistant hypercalcemia.

Biocon Share Price Update

As of October 1, 2025, at 2:10 PM IST, Biocon share price stands at ₹358.40 per share on the BSE, up by ₹3.25 or 0.91% from the previous session.

Also read: RITES inks MoU with Etihad Rail to boost UAE infrastructure ties

Published Date : 01 Oct 2025

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