Biocon once again has received the dreaded Form 483 from the US FDA but this time, the observations, as per the company, are not critical but merely procedural in nature.
The US-FDA completed a pre-approval inspection of its sterile drug product manufacturing facility in Bangalore this week and issued a Form 483 with 7 observations. As per the company, these observations were largely procedural and aimed at continuous improvement. The company said that it will respond to the FDA with a corrective and preventive action plan in a timely manner.
Biocon this week also received the preliminary report from the European Regulator post inspection of its same sterile drug product facility in Bangalore in March 2018. The report listed 6 major observations with no observation classified as critical. Here too, the company said that it will submit a corrective and preventive action plan to the European inspection agency within the stipulated time period.
The market has reacted negatively to this news; it went down over 5% to Rs.630.30 and remains in the red now at Rs.635 levels.
Analysts say that there is really no need to be overreact as these are routine observations and Biocon will soon get over these procedural issues. The company is sure to work to get these resolved as its biosimilars - Trastuzumag, Pegfilgrastim and Glargine are inching closer to the approval stage in both Europe as well as USA.