Biocon Malaysia got UK MHRA approval for its new insulin fill-finish line to support biosimilar Semglee supply in the UK and Europe.

The approval covers the facility’s new drug product fill-finish unit, the stage where the insulin is prepared and packaged into its final form before it reaches patients.

With the MHRA’s sign-off, the Malaysian plant is now cleared for commercial production of Semglee, Biocon’s biosimilar version of insulin glargine, for the UK market. This isn’t the first approval for this particular line.

Back in July this year, the same fill-finish unit had already received clearance from the European Medicines Agency, or EMA, which governs drug approvals across the European Union.

Getting both the EMA and MHRA nods within roughly two months shows the facility has been able to meet two separate sets of strict manufacturing standards in quick succession.

With both approvals now in place, Biocon expects to begin commercial supplies of Semglee from this Malaysian facility to Europe starting the second quarter of FY27.

The plant itself is described by the company as its largest integrated insulin manufacturing site in Asia.

This comes on the back of a string of other regulatory wins for Biocon over the past couple of months.

In August, the company received marketing approval in Japan for its Pegfilgrastim biosimilar, along with a supplemental approval from the US FDA for a single-dose prefilled autoinjector version of Yesintek, used to treat certain autoimmune conditions.

More recently, its Pertuzumab biosimilar, Pebrilzo, received a positive opinion from the EMA’s expert committee, moving it a step closer to marketing approval in the European Union.

Taken together, these approvals point to a busy few months of regulatory progress for Biocon’s biosimilars business, particularly across insulin and oncology products, as the company works to expand its footprint in tightly regulated Western markets.

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