The plant in India where Biocon makes the biosimilars it shares with Mylan was given a clean bill of health by the FDA last year—but not for long. The FDA posted a new Form 483 for the facility Tuesday following an inspection last month.
The most recent citation of the Bangalore plant includes only two observations, unlike in 2017 when a long list of problems led the FDA to delay approvals of the biosimilars that Mylan and Biocon were developing. The two notations, however, again spotlighted places where Biocon needs to tighten up its processes to prevent contamination of sterile drugs.
Biocon last month acknowledged the two observations and said they were part of a pre-approval inspection of a new injectables line at the plant. A separate inspection of a solid dose facility resulted in no observations. A Biocon spokesperson said in an email that the company has addressed the findings and responded to the regulator. She said Biocon remains committed to quality.
Specifically, the FDA faulted plant employees for not carefully sanitizing and inspecting its restricted-access barrier systems. The FDA didn’t like the way the plant was tracking rejected vials. Inspectors also said investigations into unexplained discrepancies didn’t always include all of the tests the FDA thought should be conducted.
When the plant ran into FDA concerns in 2017 during a preapproval inspection, Biocon initially downplayed what turned out to be an 8-page, 10-observation critique that found problems across the entire range of processes, including in aseptic processing and filling, environmental monitoring, data recording, cleaning procedures, and even in its processes for buying sterile gloves for employees. It took about 6 months for Biocon to get those issues resolved, and the efforts delayed approval of the partners’ Herceptin biosimilar by three months.
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Last June, the Indian company reported to the stock exchange in India that the FDA had issued an Establishment Inspection Report for the plant, clearing that inspection. Last year, the Indian drugmaker also struck a partnership with Novartis to produce “next generation” biosimilars.