SOMERSET, N.J. — Catalent Pharma Solutions, a leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, has 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 Korea-based biopharmaceutical company Samsung Bioepis Co., Ltd. The services will be provided at Catalent’s flagship sterile pre-filled syringe facility in Brussels, Belgium.
Used in the treatment of adults with moderate to severe rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis, SB4 is the first etanercept biosimilar to receive regulatory approval by the European Commission (EC), as Benepali. SB4 has also received regulatory approvals from Korea’s Ministry of Food and Drug Safety (MFDS), Australia’s Therapeutic Goods Administration (TGA), and Canada’s Health Canada, as BRENZYS.
“We are proud to have partnered with Samsung Bioepis on the launch of this biosimilar therapy, which was the first etanercept biosimilar to receive European Commission approval, and look forward to a continued partnership as we continue to commercial supply,” commented Jonathan Arnold, Vice President & General Manager, Drug Delivery Solutions at Catalent.
Catalent’s 265,000 square foot Brussels facility offers the latest in innovative pre-filled syringe fill-finish processing and associated packaging. With experts in technology transfer, scale-up and life-cycle management, its annual syringe filling capacity is more than 200 million units.