iifl-logo-icon 1
IIFL

Invest wise with Expert advice

By continuing, I accept the T&C and agree to receive communication on Whatsapp

  • Open Demat with exclusive Advice & Services
  • Get a dedicated Relationship Manager to help you grow your wealth
  • Exclusive advisory on 20+ trading & wealth-based investment options
  • One tap Investments, Automated trading & much more
  • Minimum 1 lakh margin required
sidebar image

Biocon soars on US market entry deal with J&J

21 Mar 2024 , 05:48 PM

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.

For feedback and suggestions, write to us at editorial@iifl.com

Branding Asia

Related Tags

  • Biocon
  • Pharma
  • US market
sidebar mobile

BLOGS AND PERSONAL FINANCE

Read More
Knowledge Centerplus
Logo

Logo IIFL Customer Care Number
(Gold/NCD/NBFC/Insurance/NPS)
1860-267-3000 / 7039-050-000

Logo IIFL Securities Support WhatsApp Number
+91 9892691696

Download The App Now

appapp
Knowledge Centerplus

Follow us on

facebooktwitterrssyoutubeinstagramlinkedin

2024, IIFL Securities Ltd. All Rights Reserved

ATTENTION INVESTORS
  • Prevent Unauthorized Transactions in your demat / trading account Update your Mobile Number/ email Id with your stock broker / Depository Participant. Receive information of your transactions directly from Exchanges on your mobile / email at the end of day and alerts on your registered mobile for all debits and other important transactions in your demat account directly from NSDL/ CDSL on the same day." - Issued in the interest of investors.
  • KYC is one time exercise while dealing in securities markets - once KYC is done through a SEBI registered intermediary (broker, DP, Mutual Fund etc.), you need not undergo the same process again when you approach another intermediary.
  • No need to issue cheques by investors while subscribing to IPO. Just write the bank account number and sign in the application form to authorise your bank to make payment in case of allotment. No worries for refund as the money remains in investor's account."

www.indiainfoline.com is part of the IIFL Group, a leading financial services player and a diversified NBFC. The site provides comprehensive and real time information on Indian corporates, sectors, financial markets and economy. On the site we feature industry and political leaders, entrepreneurs, and trend setters. The research, personal finance and market tutorial sections are widely followed by students, academia, corporates and investors among others.

RISK DISCLOSURE ON DERIVATIVES
  • 9 out of 10 individual traders in equity Futures and Options Segment, incurred net losses.
  • On an average, loss makers registered net trading loss close to Rs. 50,000.
  • Over and above the net trading losses incurred, loss makers expended an additional 28% of net trading losses as transaction costs.
  • Those making net trading profits, incurred between 15% to 50% of such profits as transaction cost.
Copyright © IIFL Securities Ltd. All rights Reserved.

Stock Broker SEBI Regn. No: INZ000164132, PMS SEBI Regn. No: INP000002213,IA SEBI Regn. No: INA000000623, SEBI RA Regn. No: INH000000248

plus
We are ISO 27001:2013 Certified.

This Certificate Demonstrates That IIFL As An Organization Has Defined And Put In Place Best-Practice Information Security Processes.

closeIcon

Get better recommendations & make better investments

Invest wise with Expert advice

By continuing, I accept the T&C and agree to receive communication on Whatsapp