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
Newsletter
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.
Pfizer Obtains Exclusive Rights to 3SBio’s Bispecific Antibody Targeting PD-1 and VEGF
July 31st 2025The licensing agreement between the two companies gives Pfizer the rights to develop, manufacture, and commercialize 3SBio’s bispecific antibody, SSGJ-707, which is in clinical trials for the treatment of a variety of cancers.
Mechanistic Hypothesis of Toxicity: Driving Decision Making in Preclinical Translation
July 31st 2025Mechanistic toxicity hypothesis is essential in guiding decision-making and predicting toxicities during the preclinical stages of drug development. The authors highlight the growing importance of integrating advanced technologies like mass spectrometry imaging into toxicology to enhance preclinical translation, foster innovation in therapeutic development, and ultimately improve drug safety and efficacy.
