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The facility was last inspected in September 2024, which had resulted in five observations. The unit in question had received an Official Action Indicated (OAI) status in October 2023.
The inspection scope included several biologics manufacturing units comprising of drug substance and one drug product manufacturing units, medical device assembly unit, analytical quality control laboratory, microbiological laboratories and two warehouses.
This also indicates a potential end to Biocon’s regulatory hurdles and also paves the way for an approval and launch of gAspart in the near-term.
Shares of Biocon had also surged close to 8% on January 7, after its drug, used in the treatment of Psoriasis, had received approval from the USFDA. In November last year, the company’s Bengaluru unit was cleared by the US Drug Regulator and the Japanese approval for Ustekinumab can lead to a potential launch in February 2025 as well.
Analysts said that assuming a $700 million market size for gAspart, Biocon can see US sales worth $25 million and $50 million in financial year 2026 and 2027.
Brokerage firm Jefferies had upgraded Biocon last week to “hold” from its earlier rating of “underperform” and raised its price target 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 had 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 had ended 2.9% lower on Friday at ₹360, in-line with the fall in broader market stocks.
