Adopting a digital-based Quality Management System will help Biocon remediate issues at its insulin glargine facility in Malaysia, the firm says.

An inspection by the US Food and Drug Administration (FDA) between June 24 and July 5 has resulted in a Form 483 with 12 observations at Indian drugmaker Biocon’s facility in Malaysia. The drug product and drug substance site will produce a follow-on insulin glargine referencing Sanofi’s Lantus intended for the US market.

“We believe these 12 observations across our three units at our facility in Malaysia are largely procedural, aimed at continuous improvement and will help us strengthen our quality management system,” Kiran Mazumdar-Shaw, chairperson and managing director at Biocon, told Bioprocess Insider.

Biocon’s Malaysia plant received a 483 with 12 observations. Image: iStock/Harvepino

While none of the observations related to data integrity, several are repeats from a pre-approval inspection carried out in February 2018, though Mazumdar-Shaw said the firm believes they are not critical but rather procedural deviations due to human error.

As such, the firm is looking to address these issues through software solutions.

“We have been working on finding long term solution to ensure zero deviations,” she said. “We have taken a decision to adopt digital solutions that will help us move away from a paper-based Quality Management System [QMS] to a paperless technology enabled integrated QMS. We believe it will help us eliminate many of these deviations, going forward.”

She added the firm is aiming to work closely with the regulator to strengthen its QMS. “We will submit a Corrective and Preventive Action Plan at the earliest and are confident of addressing these observations expeditiously.”

Insulin glargine

Biocon is looking to bring its insulin glargine product to the US and has submitted it under the 505(b)(2) regulatory pathway as a ‘follow-on’ to Lantus.

However, in June 2018 the firm received a complete response letter (CRL) from the FDA, which asked for additional clinical data in support of a manufacturing site change from Bangalore, India to the Malaysia site.

Meanwhile, Sanofi filed a lawsuit in October 2017 against Biocon’s partner Mylan alleging the product infringes on  18 patents. The suit triggered an automatic stay of 30 months, and so with an approval the firm will only be able to launch from March 2020.

Biocon has said previously it is preparing for this date to launch, and the latest 483 will not prevent this, Mazumdar-Shaw confirmed, saying: “We do not expect any change to our commercialization plans for biosimilar insulin glargine in the US.”

In Europe and other territories, the product has received approval as a biosimilar to Sanofi’s Lantus, under the name Semglee.