Seven concerns raised by the U.S. drug regulator about Biocon Ltd.’s manufacturing facility in Bengaluru are mostly procedural and unlikely to be escalated into anything serious, according to brokerages.
The observations appear benign with no data integrity issues and mainly pertain to quality and controls, which are procedural, Morgan Stanley said in a note.
Brokerage house Bernstein agrees. It said the observations are on the lighter side and can be reasonably addressed through change in procedure and additional training. More importantly, the broking firm said the observations are unlikely to delay the tentative June approval of Biocon and Mylan’s biosimilar Neulasta, which will be manufactured at the plant.
Critically, the document does not contain (i) argument of systemic or recurring problem, (ii) problems requiring change in facility structure/equipment, (iii) suggestion any of the procedure deviations created patient risk.”Aaron Gal, Bernstein
The U.S. Food and Drug Administration had inspected the biotechnology major’s unit in the first week of this month. It made seven observations, which were uploaded on the regulator’s website overnight. “We will respond to the USFDA with a corrective and preventive action plan in a timely manner,” Biocon had said in a statement to exchanges post inspection.
FDA Observations For Biocon’s Bengaluru Unit
- Disinfection efficacy is incomplete or not adequately demonstrated.
- Environmental monitoring is deficient.
- Cleaning procedures are inadequate.
- Inadequate behaviours to prevent contamination of raw materials was observed
- Operating procedures for despising does not reflect Quality Control.
- Inadequate trending analysis to identify potential issues that could impact product quality.
- Inadequate equipment qualification based on documents provided.
(Source: U.S. FDA website)