Biosimilars a regulatory perspective from America.docVIP

Kay Arthritis Research Therapy 2011,13:112 /content/13/3/112 COMMENTARY Biosimilars: a regulatory perspective from America Jonathan Kay* alternatives to targeted biological therapies are not yet Abstract available in the US or the European Union. Biosimilars are protein products that are su?ciently similar to a biopharmaceutical already approved by a regulatory agency. Several biotechnology companies and generic drug manufacturers in Asia and Europe are developing biosimilars of tumor necrosis factor inhibitors and rituximab. A biosimilar etanercept is already being marketed in Colo