Biocon shares gain on licence deal with Janssen, J&J for US markets
Biocon Share Price | In an another development, the company’s subsidiary received observations from US Food and Drug Administration (USFDA).
Biocon
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The share price of Biocon gained marginally in early trade on March 1 after its subsidiary Biocon Biologics signed a settlement and licence deal with Janssen Biotech Inc and Johnson & Johnson to market Bmab 1200, a proposed biosimilar to Stelara, in the US.
The deal licenses the company to launch the product in the US in February 2025 once it gets the US FDA approval.
The US watchdog has accepted the company’s Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway.
Biocon Biologics and Janssen have finalised the settlement agreement to dismiss the pending Inter Partes Review (IPR) for US 10961307 before the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademarks Office.
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In an another development, the company’s subsidiary received four observations from USFDA after an inspection at Biocon Biologics Limited’s Biocon Campus (Site 1) facility during February 20 to 28.
This inspection pertains exclusively to the rh-Insulin (rhI) Drug Substance (DS) supply to a customer for veterinary use and it was for a pre-approval supplement (PAS) filed by our customer late last year, company said in its exchange filing.
At the conclusion of this inspection, the agency has issued the Form 483 with four observations. “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 said.
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The outcome of this inspection does not impact the manufacturing and distribution of the company’s commercial products in the US market, it added.
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