| Company | Value | Change | %Change |
|---|
The Pharmaceuticals and Medical Devices Agency (PMDA) of Japan has approved Ustekinumab BS subcutaneous injection, a biosimilar to the reference product Stelara, the company said in an exchange filing.
The biosimilar Ustekinumab has been developed and manufactured by Biocon Biologics and will be commercialised and marketed in Japan by the company’s exclusive commercial partner, Yoshindo Inc.
Ustekinumab, which is a monoclonal antibody, is approved for the treatment of Psoriasis Vulgaris and Psoriatic Arthritis (PsA).
Biocon Biologics had entered into a settlement and licensing agreement with Janssen Biotech Inc. and Janssen Sciences Ireland, along with Johnson & Johnson, to commercialise the Ustekinumab in Japan, upon getting regulatory approvals, in August last year.
In November last year, the company’s Bengaluru unit had received a Voluntary Action Indicated (VAI) status from the USFDA for its Bengaluru unit. The US health regulator had conducted a Current Good Manufacturing Practice (cGMP) inspection along with a Pre-Licensing Inspection (PLI) at the Biocon Biologics facilities in Bengaluru from 15 July to 26 July this year.
Shares of Biocon had ended 2.8% lower on Monday at ₹359.1. The stock has risen 28% over the last 12 months.
