Biocon sheds 4%, hits 52-week low as US FDA issues form 483 for 3 sites

The US health regulator has issued Form 483s with 11 observations each for two sites in Bengaluru and six observations for a plant in Malaysia site.

Shares of Biocon hit a 52-week low of Rs 298.50 on slipping 3.6 per cent on the BSE in Thursday’s intra-day trade after US health regulator issued form 483s to the company with 11 observations each for its two sites in Bengaluru and six for a plant in Malaysia.

The stock was trading at its lowest level since April 2020. At 09:30 am; Biocon was quoting 2 per cent lower at Rs 303 vs a 1.2 per cent decline in the Sensex benchmark index. In the past three months, it has underperformed the market by falling 10 per cent as compared to a 5 per cent rally in the Sensex.

As per the US Food and Drug Administration (USFDA), Form 483 is issued at the conclusion of an inspection if an investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

The US Food and Drug Administration (US-FDA) conducted three on-site inspections at Biocon Biologics’ (company's subsidiary) seven manufacturing facilities spanning two sites in Bengaluru, India and one at Johor, Malaysia. These inspections started with the Bengaluru site on August 11, 2022 and concluded with the Malaysia site on August 30, 2022.

These inspections were initiated on account of three preapproval inspections for biosimilar Bevacizumab, rh-Insulin and Insulin Aspart and a capacity expansion inspection for biosimilar Trastuzumab. These included multiple drug substance and drug product facilities and other support infrastructure at these sites.

Biocon said that the company does not expect the outcome of these inspections to impact the current supply of its products. 

The observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerized tools to aid risk assessment & investigations and other procedural & facility upgrades, the company said.

“We will submit Corrective and Preventive Action Plans (CAPA), to the US FDA in the stipulated time frame,” Biocon said.

Biocon’s launches of bBevacizumab, bAspart and bAdalimumab, especially in the US, are expected to contribute to the near term growth of the business. With two strategic agreements signed with Serum and Viatris, Biocon is targeting revenues of $ 1.8 billion in FY24.

“We believe timely regulatory clearance and subsequent launch timeline, notably for expected FY23 launches of bAspart (CRL in September,2021) and bBevacizumab remain keys near term triggers for the company,” ICICI Securities said in a note.