Catalent To Provide Fill & Finish Services For Commercial Supply Of Samsung Bioepis' Biosimilar Therapy

Pre-Filled Syringes to be Produced at Brussels, Belgium Facility

Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, recently announced that it is to provide fill-finish production services for the commercial supply of SB4, a biosimilar referencing Enbrel ¹ (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.² 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.^3,4

“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.

About Samsung Bioepis
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of 13 biosimilar candidates that include six first-wave candidates that cover the therapeutic areas of immunology, oncology and diabetes. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, visit www.samsungbioepis.com.

About Catalent
Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 9,200 people, including over 1,400 scientists, at more than 30 facilities across five continents, and in fiscal 2016 generated $1.85B in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com.

More products. Better treatments. Reliably supplied.

¹ Enbrel is a registered trademark of Immunex Corp.

² Benepali is a registered European trademark of Biogen Idec International Holding Ltd.

³ BRENZYS has not been approved for the treatment of patients with psoriatic arthritis and plaque psoriasis in Canada

⁴ BRENZYS is a trademark of Merck Sharp & Dohme Corp.