“The company will respond to the FDA with an appropriate Corrective and Preventive Action Plan (CAPA) and are confident of addressing these observations expeditiously. The FDA has set a target action date for our insulin Glargine application in June 2020. We believe the outcome of this inspection does not, in any way, impact the commercialization plans of insulin Glargine in the US. Biocon Biologics is committed to global standards of quality and compliance,” Biocon’s spokesperson said.
As per the US FDA, Form 483 is issued to firm management at the conclusion of an inspection when investigators observe any conditions that, in their judgment, may constitute violations of the Food Drug and Cosmetic Act and related Acts.
Analysts at JP Morgan, however, have ‘overweight’ rating on Biocon with September 2020 price target of Rs 360 per share.
The brokerage firm thinks the company is well positioned in the emerging biosimilar markets
supported by its R&D capabilities, deep pipeline and strong management team. "Over the last few years, the company has seen success in its biologic development with a spate of approvals in the US/EU and focus has shifted to the earnings potential from its pipeline investment. Key catalysts for the stock would be the momentum in recent launches and new filings/approvals in the US," it said in a recent report.
At 11:46 am, Biocon was up 2 per cent at Rs 321 on the BSE, as compared to a 0.91 per cent decline in the S&P BSE Sensex. A combined 6.4 million shares have changed hands on the counter on the NSE and BSE so far.