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Biocon Says FDA Issues Form 483 to Insulin Plant in Malaysia


This is the third Form 483 Biocon has received for the insulin plant in 3 years.

Biocon said this week it received a Form 483 letter from the FDA related to an inspection at its insulin manufacturing plant in Malaysia, where the company will produce its insulin glargine product, referencing Sanofi’s Lantus.

In a filing with India’s stock exchange, Biocon said the FDA conducted a pre-approval inspection of the facility between February 10 and February 21. The notice includes “3 observations, which we believe are procedural in nature,” the company wrote.

The follow-on product is already authorized in the European and Australian markets, where the product is regulated as a biosimilar and is sold under the brand name Semglee.

In the United States, the product has a target action date set for June; Biocon said in its announcement it does not “believe the outcome of this inspection does not in any way impact the commercialization plans."

However, Biocon’s Malaysian plant has been the subject of numerous regulatory challenges in 2018 and 2019. The company received a Form 483 from the FDA, inclusive of 6 observations, in 2018, and another inspection of the site in June and July 2019 yielded another Form 483 with 12 observations.

In August 2019, it received a certificate of good manufacturing practice from the European Medicines Agency’s Irish inspection authority.

With the latest notice, Biocon said it is confident of addressing the observations "expeditiously" and said it is committed to "global standards of Quality and Compliance."

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