Download Company Statement

Japan Health Authority (PMDA) Approves Biocon Biologics’ Ustekinumab BS, Biosimilar to J&J’s Stelara®

NOTIFICATION TO STOCK EXCHANGE

COMPANY STATEMENT

Bengaluru, Karnataka, India, January 07, 2025

Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), announced today that the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan has approved Ustekinumab BS subcutaneous injection [YD], a biosimilar to the reference product, Stelara® (Ustekinumab). The biosimilar Ustekinumab has been developed and manufactured by the Company and will be commercialized and marketed in Japan by the Company’s exclusive commercial partner, Yoshindo Inc.

Ustekinumab, a monoclonal antibody, is approved for the treatment of Psoriasis Vulgaris and Psoriatic Arthritis (PsA).

Biocon Biologics Ltd previously notified the Stock Exchange on Aug 29, 2024, that the Company had entered into a settlement and licensing agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson (collectively known as Janssen) to commercialize Ustekinumab in Japan, upon regulatory approval.

For more information: seema.ahuja@biocon.com

Connect with us

Subscribe

Our Parent Company

Quick Links

Our Parent Company
Facebook-f Youtube Linkedin-in

© 2025, Biocon Biologics Limited (a Subsidiary of Biocon Limited). All Rights Reserved

Leaving the Biocon Biologics Corporate Website

You are now leaving the Biocon Biologics Corporate website for a Biocon Biologics EU Corporate microsite that is solely responsible for its content, including its compliance with guidelines applicable in certain geographies. Links to Biocon Biologics affiliate sites are provided as a resource to our visitors and may not be governed by the same regulatory requirements applicable to this site and unaffiliated third party sites are subject to their own terms and data protection notices and practices. Moreover, if their third party site is subject to other country laws, regulatory requirements, data protection requirements or medical practices may differ between countries and the information provided therein may not be suitable for use in your country.

Agree

Leaving the Biocon Biologics Corporate Website

You are now leaving the Biocon Biologics Corporate website for a Biocon Biologics U.S. Corporate microsite that is solely responsible for its content, including its compliance with guidelines applicable in certain geographies. Links to Biocon Biologics affiliate sites are provided as a resource to our visitors and may not be governed by the same regulatory requirements applicable to this site and unaffiliated third party sites are subject to their own terms and data protection notices and practices. Moreover, if their third party site is subject to other country laws, regulatory requirements, data protection requirements or medical practices may differ between countries and the information provided therein may not be suitable for use in your country.

Agree

Leaving the Biocon Biologics site

You are now leaving the Biocon Biologics page for a Biocon Biologics affiliate site or third party site that is solely responsible for its content, including its compliance with guidelines applicable in certain geographies. Links to Biocon Biologics affiliate sites and third party sites are provided as a resource to our visitors and may not be governed by the same regulatory requirements applicable to this site and unaffiliated third party sites are subject to their own terms and data protection notices and practices. Moreover, if their third party site is subject to other country laws, regulatory requirements, data protection requirements or medical practices may differ between countries and the information provided therein may not be suitable for use in your country.

Agree