Biocon soars on US market entry deal with J&J

1 Mar 2024 , 11:31 AM

Early on March 1, Biocon’s stock price increased somewhat after its subsidiary Biocon Biologics inked a settlement and license agreement with Johnson & Johnson and Janssen Biotech Inc. to market Bmab 1200, a planned biosimilar to Stelara, in the United States.

Under the terms of the agreement, the product may be introduced in the US in February 2025 after receiving FDA approval. 

The company’s Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) has been accepted for review under the 351(k) pathway by the US FDA. 

The settlement agreement between Biocon Biologics and Janssen to dismiss the ongoing Inter Partes Review (IPR) for US 10961307 before the US Patent and Trademarks Office’s Patent Trial and Appeal Board (PTAB) has been finalized.

In a related event, the USFDA issued four observations to the company’s subsidiary during an examination of Biocon Biologics Limited’s Biocon Campus (Site 1) facility on February 20–28.

According to the business in its exchange filing, this inspection is limited to the rh-Insulin (rhI) Drug Substance (DS) supplied to a customer for veterinary use. It was conducted in response to a pre-approval supplement (PAS) that our customer filed late last year. 

The agency has released the Form 483 with four observations following this inspection. ‘The company will submit a comprehensive Corrective and Preventive Action (CAPA) Plan to the USFDA within the stipulated time and is committed to addressing these observations expeditiously,’ it stated. 

It further stated that the results of this examination have no bearing on how the company produces and distributes its commercial goods in the US market.

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