Biocon downplays FDA Form 483 for Bangalore plant

The FDA has cited a Biocon API plant in Bangalore with eight observations.

An FDA inspection of a Biocon API plant in Bangalore that concluded last month found a number of issues, including with the plant’s quality-assurance department. But the Indian drugmaker shrugged it off Wednesday in a public statement essentially saying, So what? This is the kind of thing that happens in the regular course of business.

“With reference to Media Reports on USFDA 483s for Biocon, observations on form 483 is a standard outcome of any audit,” the company said in a statement that it sent Wednesday to the Bombay Stock Exchange. “Biocon has already responded to USFDA on all observations of the recent audit within stipulated timelines.”

It also noted that it has a “good track record of inspections” with regulators from the U.S., EU and other countries.

That is true. While for many Indian drugmakers, a Form 483 has been simply a prelude to an FDA warning letter, Biocon’s facilities have been free of those kinds of stepped-up enforcement actions.

The highly redacted six-page inspection report had eight observations for the plant, which makes a number of statin APIs as well as insulin. Those included the fact that the plant didn’t seem to always follow its own written procedures in processing and holding bulk product.

It also noted that the quality-assurance unit has used documents that don’t “assure appropriate production testing,” including releasing batches with out-of-specification test results when the unit decides in a final assessment that the deviation does not impact that batch. The inspectors were also concerned that some solutions were not tested for bioburden and found that bioburden sampling during manufacturing was not adequate.

Biocon’s attention has been focused more recently on obtaining FDA approval of the Herceptin biosimilar it developed with Mylan. The two announced last fall that they had submitted their candidate to the FDA for consideration. The pair is gunning for the chance to be the first Herceptin copycat to market and therefore the first to scoop up a share of Herceptin's blockbuster sales, which totaled $6.7 billion last year.