Remicade: genotox, carcinogenicity and repro: done or skipped?

“Genotoxicity tests are considered to be of limited value for this type of product. Still, a complete test battery has been performed. Infliximab did not show any genotoxic activity in these studies.”

“These data gave no support for the hypothesis that inhibition of TNFα is associated with an enhanced risk for tumour development.”

“In these experiments, it was demonstrated that cV1q crossed the placenta but there was no indication of impairment of reproductive function, embryotoxicity or teratogenicity.”

“Genotoxicity tests are considered to be of limited value for this type of product. Still, a complete test battery has been performed. Infliximab did not show any genotoxic activity in these studies.”

“Genotoxicity tests are considered to be of limited value for this type of product. Still, a complete test battery has been performed. Infliximab did not show any genotoxic activity in these studies.”

“Genotoxicity tests are considered to be of limited value for this type of product. Still, a complete test battery has been performed. Infliximab did not show any genotoxic activity in these studies.”

“A 6-month study in CD-1 mice was conducted to assess the tumorigenic potential of cV1q anti-mouse TNFα, an analogous antibody. No evidence of tumorigenicity was observed in mice that received intravenous doses of 10 mg/kg or 40 mg/kg cV1q given weekly.”

“A 6 months toxicity study with an anti-mouse TNFα monoclonal antibody (chimeric V1q muG2a, which has functional characteristics similar to infliximab) was submitted in year 2001.”