More trouble for Biocon insulin plant in Malaysia as FDA flags 6 Form 483 observations

Biocon Malaysia insulin plant
Before it was approved by the FDA in April 2020, Biocon's insulin plant in Malaysia was hit with two complete response letters. (Biocon)

The road to certification for Biocon’s insulin facility in Malaysia was long, winding and full of potholes. Now comes a detour.

The FDA has slapped the factory with Form 483, citing six observations that need to be addressed, the company said. The site makes the high-profile interchangeable insulin Semglee, but Biocon doesn't expect the latest inspection to derail the launch.

Biocon didn't disclose the specific nature of the problems, but said the issues were related to “drug substance, drug product and devices facilities.” FDA inspectors found the problems during a visit from September 13 to 24.

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The site has a long, troubled history. Twice in a span of 15 months, it was sidelined by the FDA with complete response letters. The second, in August 2019, came after the FDA flagged problems during a pre-approval inspection.

Another inspection of the plant in February 2020 produced three Form 483 observations. 

The FDA finally blessed the factory last April, clearing the way for the production of Biocon and Viatris’ Semglee, generic insulin that snared a prized interchangeability tag two months ago. That interchangeability tag allows the med to be substituted for Sanofi's Lantus at U.S. pharmacy counters.

RELATED: Viatris, Biocon snare historic interchangeability tag in diabetes for Lantus biosimilar

Even with the latest hiccup, Biocon doesn't "expect the outcome of this inspection to impact our commercialization plans," the company said in a statement on its website.

“We are confident of addressing these observations through procedural enhancements and an appropriate corrective and preventive action plan, which will be submitted to the FDA in the stipulated time,” the company added.