FDA Issues New Form 483 to Biocon Over Bangalore Facility

Biosimilar developer Biocon has received the FDA’s Form 483 after a preapproval inspection of its Bangalore manufacturing facility resulted in 7 observations. The FDA issues Form 483 when an investigator conducting an inspection has observed conditions that may constitute violations of the Food, Drug, and Cosmetic Act or related acts.

In the same week, Biocon revealed, it received a preliminary report from a European regulatory inspection of the same facility. The European report notes 6 “major” observations. A spokesperson for the company said in a statement that Biocon will respond to both of the regulatory bodies with corrective and preventive action plans in a timely fashion.

These regulatory setbacks for Biocon are not the first in recent days for Biocon; separately, in February 2018, Biocon received a Form 483—noting 6 observations—for its manufacturing facility in Malaysia, where it plans to manufacture its insulin products, and the Bangalore facility, which manufactures monoclonal antibodies, was the subject of a 2017 Form 483, as well as a 2017 French National Agency for Medicines and Health Products Safety non-compliance statement.

The French inspection found 35 problems, 11 of which were deemed major, and related to environmental monitoring, training, cross-contamination risks, cleaning validation, and process validation, among others. On the heels of that noncompliance statement, Biocon withdrew from the European Medicines Agency its applications for 2 biosimilars, trastuzumab and pegfilgrastim, saying that the regulatory body would reinspect the facility after corrective and preventive actions had been undertaken, and that Biocon would resubmit its applications after a new inspection had been completed.

Currently, the FDA has approved Biocon’s trastuzumab biosimilar, Ogivri, although the drug has not yet been launched in the United States. The FDA rejected another proposed Biocon biosimilar, MYL-1401H, a pegfilgrastim product referencing Neulasta. According to Biocon, the FDA’s Complete Response Letter (CRL) for the proposed drug relates to “data from facility requalification activities” after recent modifications to its manufacturing plant, and the CRL did not raise questions concerning the drug’s biosimilarity, pharmacokinetic or pharmacodynamic data, clinical data, or immunogenicity.