Biocon gets USFDA's tentative approval for antibacterial drug Rifaximin

The USFDA's tentative approval means Biocon Pharma's Rifaximin 550 mg meets regulatory requirements but cannot be marketed in the US yet due to patents or exclusivity on the original drug

Indian biopharma firm Biocon on Tuesday announced that its wholly owned subsidiary Biocon Pharma has received tentative approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Rifaximin tablets, 550 mg, developed in partnership with US-based Carnegie Pharmaceuticals LLC.

 

The drug, a rifamycin antibacterial, is used to reduce the risk of recurrence of a liver-related condition called overt hepatic encephalopathy (HE) and to treat irritable bowel syndrome with diarrhoea (IBS-D) in adults.

 

According to the FDA, a tentative approval is a notification issued to drugs that otherwise meet the statutory and regulatory requirements for approval but cannot be approved for marketing in the United States because of patents or exclusivities related to the reference listed drug (RLD) upon which they rely. 

 

 

Earlier this month, Biocon also announced that its subsidiary, Biocon Biologics, has signed a settlement and licence agreement with Amgen Inc, clearing the way for the US launch of two biosimilars used to treat osteoporosis and cancer-related bone conditions.

 

According to a regulatory filing, the pact covers the commercialisation of Bosaya and Aukelso in the US.

 

"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 Chief Executive Officer and Managing Director Shreehas Tambe said.

 

Biocon quarterly results

 

Bengaluru-based Biocon reported a sharp 95.2 per cent year-on-year decline in consolidated net profit, which fell to ₹31 crore in the first quarter of financial year 2025-26 (Q1 FY26) from ₹660 crore in the same period last year. The Q1 FY25 profit included a one-time divestment gain, impacting this year’s base.

 

On a like-for-like basis, after adjusting for the one-time gain, consolidated revenue rose 15 per cent to ₹4,022 crore. Operating revenue for Q1 FY26 increased 15 per cent to ₹3,942 crore, up from ₹3,433 crore in Q1 FY25. Earnings before interest, taxes, depreciation and amortisation (Ebitda) stood at ₹829 crore, up 19 per cent, with the Ebitda margin maintained at 21 per cent.

 

During the quarter, key developments included the launch of Yesafili in Canada and USFDA approval for Insulin Aspart, marking Biocon’s second interchangeable biosimilar insulin.