Biocon Pharma, a wholly owned subsidiary of Biocon Ltd., in partnership with Carnegie Pharmaceuticals, has received tentative approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Rifaximin Tablets, 550 mg.

Rifaximin tablets are a rifamycin antibacterial indicated for reducing the risk of overt hepatic encephalopathy (HE) recurrence and to treat irritable bowel syndrome with diarrhoea (IBS-D) in adults.  

This approval follows a significant development last week, when Biocon Biologics — Biocon Ltd.’s fully integrated global biosimilars subsidiary — announced a settlement and license agreement with Amgen, paving the way for the US commercialisation of its biosimilars Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq).

Bosaya 60 mg/mL injection in a single-dose prefilled syringe (PFS) and Aukelso 120 mg/1.7 mL (70 mg/mL) injection in a single-dose vial are biosimilars to Amgen’s Prolia and Xgeva, respectively. These therapies are used in the treatment of osteoporosis and cancer-related bone conditions.