Biocon USFDA Approval

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

By 10:35 AM, Biocon share price was trading 2.84 per cent higher at ₹364.45 per share. In comparison, BSE Sensex was trading 0.38 per cent higher at 83,004.53 levels.

Biocon Biologics gets USFDA approval for Bosaya and Aukelso, denosumab biosimilars of Prolia and Xgeva, with provisional interchangeability status to widen patient access

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Biotechnology firm Biocon said its subsidiary has received approval from the US health regulator to market a generic medication to treat chronic heart failure. Biocon Pharma has received approval of its ANDA for Sacubitril/Valsartan Tablets, in 24 mg/26 mg, 49 mg/51 mg and 97 mg/103 mg strengths, from the US Food and Drug Administration (USFDA), the company said in a regulatory filing. Sacubitril and valsartan combination is used to treat chronic heart failure in adults to help reduce the risk of death and hospitalisation. The medicine is also used to treat paediatric patients over the age of one year. The approval further adds to Biocon's portfolio of vertically integrated, complex drug products, the company said.

Company says approval is a 'significant milestone' and marks entry in new therapeutic area in the US

The company, helmed by Kiran Mazumdar Shaw, is leading the charge among Indian drugmakers - the world's largest supplier of generic medicines - as they race to grab a slice of the obesity drugs market

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The generic API business has been one of the primary businesses for Biocon, however, in recent years, the segment's contribution towards the company's consolidated financials has declined

Biocon Ltd on Wednesday said the US health regulator has classified as 'official action indicated' for the manufacturing facility of group firm Biocon Sdn Bhd at Johor, Malaysia following an inspection. The OAI (official action indicated) status may cause delay and/or withholding of pending product approvals or supplements from the facility, Biocon Ltd said in a regulatory filing. "Biocon Sdn Bhd, a step-down subsidiary of Biocon Biologics Ltd, has received a communication from the US Food and Drug Administration (FDA) pursuant to its July 2023 cGMP inspection at its insulins manufacturing facility at Johor, Malaysia," a company spokesperson said in the filing. The USFDA has "determined the inspection classification as 'OAI' (Official Action Indicated). The OAI status may cause delay and/or withholding of pending product approvals or supplements from the facility", the spokesperson added. As per the USFDA, OAI implies that the regulator may withhold approval of any pending product

The USFDA has determined the inspection classification as 'OAI' (Official Action Indicated) post inspection of Biocon's step-down subsidiary in Malaysia.

The company aims to launch about 60 new products in the next three years in the US market

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The product is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant

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The US Food and Drug Administration's (USFDA's) nod to Biocon's supplemental biologics licence application for the new unit will expand the company's capacity multifold, the company said