Catalent to Provide Fill and Finish Services for Samsung Bioepis’ Biosimilar

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Prefilled syringes for commercial supply of the etanercept biosimilar will be produced at Catalent’s Brussels facility in Belgium.

Catalent Pharma Solutions announced that it is to provide fill-finish production services for the commercial supply of SB4, a biosimilar referencing Enbrel (etanercept), on behalf of the Korean biopharmaceutical company Samsung Bioepis. The services will be provided at Catalent’s sterile prefilled syringe facility in Brussels, Belgium.

SB4 is the first etanercept biosimilar to receive European approval as Benepali for the treatment of moderate to severe rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis. The biosimilar has also received regulatory approvals in Korea, Australia, and Canada, as Brenzys.

Catalent’s 265,000 square foot Brussels facility offers innovative prefilled syringe fill-finish processing and associated packaging. It specializes in technology transfer, scale-up, and life-cycle management, with an annual syringe filling capacity of more than 200 million units.


Source: Catalent