Catalent Pharma Solutions has partnered with Korea-based Samsung Bioepis Co. to provide fill-finish production services for the commercial supply of SB4, a biosimilar referencing Enbrel (etanercept), which is used in the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis. Catalent will provide the services from its 265,000 sq.-ft. sterile pre-filled syringe facility in Brussels, Belgium.
 
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,” said Jonathan Arnold, vice president and general manager, Drug Delivery Solutions at Catalent.
 
Enbrel is a registered trademark of Immunex Corp.
Benepali is a registered European trademark of Biogen
BRENZYS, a trademark of Merck Sharp & Dohme Corp., has not been approved for the treatment of patients with psoriatic arthritis and plaque psoriasis in Canada