Biocon’s key biosimilars plant in Bengaluru, India, has gotten mixed reviews from the FDA. And in its most recent viewing, inspectors found a handful of issues.
The company today reported that the agency issued a Form 483 with five observations following a preapproval and good manufacturing practices inspection last week. It didn’t say what product it is hoping to get approved for production at the plant or what the issues are but pledged to get on them.
“We will respond to the FDA with a Corrective and Preventive Action Plan (CAPA) and are confident of addressing these observations expeditiously. We remain committed to global standards of Quality and Compliance,” Biocon said in a statement.
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Just days earlier, in its quarterly report, Biocon pointed out that in August the FDA had issued an Establishment Inspection Report from the FDA stating the agency had closed its inspection of the Biologics Drug Product facility in Bengaluru. In December, the agency greenlighted the facility to manufacture the drug substance for Fulphila (pegfilgrastim), which it is making for Mylan. The drug, a blood cell booster for cancer patients, is Mylan’s knockoff of Amgen’s Neulasta.
Earlier in 2019, Biocon acknowledged the plant received two observations as part of a preapproval inspection of a new injectables line at the plant, but an inspection of a solid dose facility resulted in no observations. The company also has had issues with its plant in Malaysia that will produce a copy of Sanofi’s Lantus for Mylan.
