Biocon USFDA Approval

Notably, Biocon share price has surged about 6 per cent in the last two sessions

YESINTEK, a monoclonal antibody, is approved for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis

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

Siddharth Mittal outlines the growth strategies and challenges ahead

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

In an interview, Arun Chandravarkar explains why a company must continue investing in R&D despite the impact on short-term Ebitda

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

In a Q&A, Shreehas Tambe talks about the road ahead for the firm's biosimilars business and how its alliance with Serum is projected to pan out

The application seeks approval of biosimilar bevacizumab for treatment of patients with metastatic colorectal cancer in addition to other ailments

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

Biocon Biologics, through its partner Mylan, has commercialised three of its co-developed biosimilars in developed markets like the US, Canada, the European Union and Australia.

We have at least a five-year head start in biosimilars compared with other Indian drugmakers, says Mazumdar-Shaw