Samsung Bioepis, Catalent in Supply Pact for Enbrel BiosimilarBy
Catalent Pharma Solutions has agreed to provide fill-finish production services for the commercial supply of SB4, a biosimilar referencing Amgen’s anti-inflammatory product, Enbrel (etanercept), on behalf of Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen. The services will be provided at Catalent’s sterile pre-filled syringe facility in Brussels, Belgium.
Enbrel is Amgen’s top-selling product with 2015 sales of $5.4 billion. In the US, Enbrel is indicated for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis in patients aged 2 years or older, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.
SB4 received regulatory approval as Benepali by the European Commission for the treatment of adults with moderate-to-severe rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, and plaque psoriasisis. SB4 has also received regulatory approvals from Korea’s Ministry of Food and Drug Safety, Australia’s Therapeutic Goods Administration (TGA), and Canada’s Health Canada, as Brenzys.
Source: Catalent Pharma Solutions