Biocon arm gets complete response letter from USFDA for Bevacizumab biosimilar licence application

The company said that the CRL did not identify any outstanding scientific issues on the dossier.

The letter has highlighted the need for the completion of a pre-approval inspection of the Bevacizumab manufacturing facility, the company said.

Biocon mentioned that it continues to be engaged with the USFDA and is hopeful of bringing affordable biosimilar Bevacizumab to the US market.

The drug maker reported a net profit at ₹660 crore for the December quarter against a loss of ₹42 crore in the year-ago quarter on the back of other income. The company reported a consolidated revenue of ₹4,519 crore for the December quarter of FY24, driven by 65% growth in biosimilars and 9% growth in Research Services.

Consolidated operating profit or EBITDA jumped 106% year-on-year to ₹1,492 crore.

On Biocon Biologics Ltd, which is an integrated biosimilars company and a subsidiary of Biocon, the company said the business delivered 65% year-on-year growth during the quarter.

The company continued to see robust demand for its products with market shares increasing across geographies. BBL onboarded new customers and won several key tenders, Biocon mentioned in its statement.

Biocon shares were trading 3.69% lower at ₹274.2 apiece at 10.30am. The stock is in the F&O ban, which means no new positions can be created.