Biosimilars

Differences in clinical studies and pharmacovigilance of biological drugs in Latin America

Biosimilars/Research | Posted 14/01/2022

Clinical studies are trials conducted in humans to test the efficacy of new drugs, devices, and other forms of treatment, as well as those already approved. On the other hand, preclinical or non-clinical studies are in vitro or in vivo studies, carried out on animals, which are necessary to evaluate the toxicity of the product and prove drug safety.

Etanercept biosimilars delayed until 2029 in US

Biosimilars/News | Posted 14/01/2022

Yet another patent challenge to Amgen’s originator etanercept, Enbrel, has been denied in the US.