Indian biopharmaceutical company Biocon Ltd 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 collaboration with US-based Carnegie Pharmaceuticals LLC.
Rifaximin, a rifamycin antibacterial, is prescribed to reduce the risk of recurrence of overt hepatic encephalopathy (HE)—a liver-related condition—and to treat irritable bowel syndrome with diarrhoea (IBS-D) in adults.
As per the USFDA, tentative approval is granted to drug applications that meet all regulatory and statutory standards for approval but cannot yet be marketed in the United States due to existing patents or exclusivities associated with the reference listed drug (RLD).
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Earlier this month, Biocon Biologics, another Biocon subsidiary, announced a settlement and licence agreement with Amgen Inc., paving the way for the **US launch of two biosimilars—Bosaya and Aukelso—**used in the treatment of osteoporosis and cancer-related bone conditions.
According to the company’s regulatory filing, the agreement covers the commercialisation of Bosaya and Aukelso in the United States.
Commenting on the development, Biocon Biologics Chief Executive Officer and Managing Director Shreehas Tambe said:
“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.”
The tentative approval for Rifaximin and the recent biosimilar agreements mark another step in Biocon’s ongoing efforts to expand its global presence in the US generics and biosimilars market.
