Biocon inks settlement, license pact with Amgen to market biosimilars in US

Biotechnology firm Biocon on Wednesday said its unit has inked a settlement and license agreement with Amgen Inc., paving the way for commercialisation of two biosimilars used in the treatment of osteoporosis and cancer-related bone conditions.

Biocon Biologics has inked the pact with Amgen Inc for the commercialisation of Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq) in the US, the company said in a regulatory filing.

Bosaya 60 mg/mL injection in a single-dose prefilled syringe (PFS) and Aukelso 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial are biosimilars to Amgen's Prolia and Xgeva, respectively.

These products are used in the treatment of osteoporosis and cancer-related bone conditions.

 

Biocon Biologics and Amgen executed the settlement agreement to resolve the pending patent litigation at the US District Court for the District of New Jersey, the Bengaluru-based firm said.

The agreement enables Biocon Biologics to launch Bosaya and Aukelso in the US from October 1, 2025.

"This settlement paves the way for Biocon Biologics to bring our high-quality denosumab biosimilars, Aukelso and Bosaya, to patients and healthcare providers in the US," Biocon Biologics CEO & Managing Director Shreehas Tambe said.

"These therapies will not only strengthen our oncology portfolio but also mark our entry into the bone health space - an important step as we continue to broaden access to life-changing biologics for patients across therapeutic areas," he added.

The US Food and Drug Administration had approved Bosaya and Aukelso in September 2025.

Biocon shares were trading 1.88 per cent up at Rs 347.25 apiece on the BSE.