Biocon shares gain 8% after Psoriasis drug approval from Japan, Jefferies upgrade

Biocon Biologics Ltd. a unit of Biocon Ltd. has informed the exchanges on Tuesday, January 7, that the company has received the approval from the Japanese drug authority for a drug used in the treatment of Psoriasis. In response, the stock has risen 8%.

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.

Brokerage firm Jefferies upgraded Biocon to "hold" from its earlier rating of "underperform" on TUESDAY> The brokerage has also revised its price target on Biocon higher to ₹400 from ₹280 earlier.

Jefferies said that the growth visibility for the biologics business has increased. Among the key events to watch for Biocon in 2025, Jefferies highlighted the USFDA classification of its Malaysia plant, the approval for bAspart and a market share ramp-up in bStelara, bHumira, bAspart and generic Semaglutid.

Shares of Biocon are currently trading 7.6% higher on Tuesday at ₹385.