Catalent to Provide Fill and Finish Services for Samsung Bioepis’ Biosimilar
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
EMA Recommends Imfinzi-Based Perioperative Regimen for Treating Resectable NSCLC
March 10th 2025The committee’s recommendation is based on results from a Phase III trial in which Imfinzi demonstrated a reduced risk of recurrence, progression, or death by 32% compared to neoadjuvant chemotherapy alone.
