Shares of Biocon were trading 4% higher on 13 January after the company’s subsidiary Biocon Biologics’ insulin factory in Malaysia got cleared by the US Food and Drug Administration (USFDA), removing a major regulatory barrier.

The US drug authorities classified the Malaysian plant as a “Voluntary Action Indicated” (VAI), enabling the company to continue filing products from that establishment.

This comes after the unit was designated as an Official Action Indicated (OAI) in October 2023. In addition, the US regulator issued five observations during its inspection of the site in September.

The facility can continue operating normally because the FDA’s VAI designation identifies minor, non-critical problems that don’t call for further regulatory action. Conversely, an OAI classification indicates major infractions, such as non-compliance with GMP, and may result in license denial, import alerts, or warning letters. To put things right, the institution needs to address these problems and go through another inspection.

Thus, Biocon’s regulatory battles ended when the Malaysian business was reclassified from its prior OAI status to a VAI classification. This also made it possible for Aspart, an insulin biosimilar medication, to be authorized and made available.

Following the USFDA’s November 2024 VAI designation of Biocon Biologics’ Bengaluru factory, the focus shifted to securing regulatory approval for the Malaysian facility.

At 12:33 pm, the shares of Biocon were trading 0.84% higher at Rs 364 on NSE. 

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