The inspection conducted by the US Food and Drug Administration (FDA) on the Malaysian Insulin Facilities of leading biotechnology giant Biocon resulted with a Form 483. The US regulating body has issued 12 observations that fall under the category of ‘objectionable conditions’ prevalent during the inspection. Biocon in partnership with Mylan, is contesting to compete with Sanofi’s Lantus. The pre-approval inspection (PAI) was conducted on the insulin glargine drug substance, drug product, and device assembly facilities in the Malaysia plant. This isn’t the first time that Biocon has had a run-in with the regulating body. In June 2018, the FDA issued a Form 483 with six observations after its first pre-approval inspection.
“We will respond to the FDA with a corrective and preventive action plan and are confident of addressing these observations expeditiously,”observed a spokesperson for the company.
Despite these setbacks, Biocon released a statement that this is unlikely to affect its plan of commercializing the drug in the US markets. The Managing Director, Kiran Mazumdar-Shaw, responded by saying that the observations were ‘largely procedural’ and that the ‘silly human errors’ would be swiftly dealt with. The insulin glargine has already been approved in India, Japan, Australia, the EU, and a dozen other countries. It is an injection used to treat type-1 and type-2 diabetes. It is yet to be seen if the delays in the approval will affect Biocon and Mylan’s goal of challenging its competitors who have already made a mark in the market.
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