Infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease. Psoriasis: Flixabi is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet A (PUVA).’ Product Information The Product Information (PI) approved with the submission trial is described in this AusPAR can be found as Attachment 1. For the most recent PI, please refer to the TGA website at <>. II. Quality findings Drug substance (active ingredient) Infliximab (SB2) is a chimeric human/mouse monoclonal antibody (mAb), which is typically a shaped large glycoprotein consisting of four polypeptide chains (two ‘Y’ identical heavy chains (HC) and two identical light chains (LC)), connected by disulphide bonds. Each chain presents constant and variable regions whereby in both chains, the variable region is murine whereas the constant region is of human origin (IgG1 and human kappa origins for the HC and LC, respectively). The molecular weight of SB2 is approximately 149 kilodalton (kDa) in glycosylated form. is 1 N-linked glycosylation site is located at asparagine 300 on each HC. There are no O-linked glycosylation sites. Drug substance manufacture The SB2 drug substance manufacturing process involves cell culture expansion, production in a bioreactor, harvest of the cell culture fluid (CCF), purification and dispensing, resulting in highly purified SB2 drug substance. All drug substance manufacturing are validated. Stability Stability data have been generated real time and accelerated conditions. Drug product The finished drug product is as 100 mg of a powder in a glass vial for intravenous (IV) injection. Drug product manufacture The drug product manufacturing process involves thawing of the formulated drug substance, mixing, bioburden reduction filtration, pooling, sterile filtration, filling lyophilisation and stoppering. A detailed description of the drug product manufacturing process has been provided.
Infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease. Psoriasis: Flixabi is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet A (PUVA).’ Product Information The Product Information (PI) approved with the submission is described in this AusPAR can be found as Attachment 1. For the most recent PI, please refer to the TGA website at <>. II. Quality findings Drug substance (active ingredient) Infliximab (SB2) is a chimeric human/mouse monoclonal antibody (mAb), which is typically a ‘Y’ shaped large glycoprotein consisting of four polypeptide chains (two identical heavy chains (HC) and two identical light chains (LC)), connected by disulphide bonds. Each chain presents constant and variable regions whereby in both chains, the variable region is murine whereas the constant region is of human origin (IgG1 and human kappa origins for the HC and LC, respectively). The molecular weight of SB2 is approximately 149 kilodalton (kDa) in glycosylated form. is 1 N-linked glycosylation site is located at asparagine 300 on each HC. There are no O-linked glycosylation sites. Drug substance manufacture The SB2 drug substance manufacturing process involves cell culture expansion, production in a bioreactor, harvest of the cell culture fluid (CCF), purification and dispensing, resulting in highly purified SB2 drug substance. All drug substance manufacturing are validated. Stability Stability data have been generated real time and accelerated conditions. Drug product The finished drug product is as 100 mg of a powder in a glass vial for intravenous (IV) injection. Drug product manufacture The drug product manufacturing process involves thawing of the formulated drug substance, mixing, bioburden reduction filtration, pooling, sterile filtration, filling lyophilisation and stoppering. A detailed description of the drug product manufacturing process has been provided. trial
auspar-infliximab-171012.docx