Cornelius F. Waller, MD

The patent expiration of several biopharmaceuticals such as erythropoietin (erythropoiesis-stimulating agents, ESAs), granulocyte colony-stimulating factor (G-CSF, filgrastim) and others, has led to the emergence of biosimilar medicines. These are defined as copy versions of approved medicinal products with demonstrated similarity in physicochemical characteristics, efficacy, and safety based on a comprehensive comparability exercise. Strict guidelines for the development of biosimilars, ranging from preclinical to phase III trials and postmarketing studies, are already in place in Europe, and the United States Food and Drug Administration (FDA) recently issued draft guidance on biosimilars. A number of biosimilar ESAs and G-CSFs have been approved. Biosimilar monoclonal antibodies are an attractive target for development, with draft guidance from the European Medicines Agency currently under review. Biosimilar medicines may provide cost-effective alternatives to their branded counterparts, potentially benefitting public health by improving access to these medications. It is therefore important to raise awareness of these products among treating physicians. Furthermore, finalization of FDA guidance is important for the development of biosimilar medicines for the US market...

*For a PDF of the full article, click on the link to the left of this introduction.

The patent expiration of several biopharmaceuticals such as erythropoietin (erythropoiesis-stimulating agents, ESAs), granulocyte colony-stimulating factor (G-CSF, filgrastim) and others, has led to the emergence of biosimilar medicines. These are defined as copy versions of approved medicinal products with demonstrated similarity in physicochemical characteristics, efficacy, and safety based on a comprehensive comparability exercise. Strict guidelines for the development of biosimilars, ranging from preclinical to phase III trials and postmarketing studies, are already in place in Europe, and the United States Food and Drug Administration (FDA) recently issued draft guidance on biosimilars. A number of biosimilar ESAs and G-CSFs have been approved. Biosimilar monoclonal antibodies are an attractive target for development, with draft guidance from the European Medicines Agency currently under review. Biosimilar medicines may provide cost-effective alternatives to their branded counterparts, potentially benefitting public health by improving access to these medications. It is therefore important to raise awareness of these products among treating physicians. Furthermore, finalization of FDA guidance is important for the development of biosimilar medicines for the US market...

*For a PDF of the full article, click on the link to the left of this introduction.

The patent expiration of several biopharmaceuticals such as erythropoietin (erythropoiesis-stimulating agents, ESAs), granulocyte colony-stimulating factor (G-CSF, filgrastim) and others, has led to the emergence of biosimilar medicines. These are defined as copy versions of approved medicinal products with demonstrated similarity in physicochemical characteristics, efficacy, and safety based on a comprehensive comparability exercise. Strict guidelines for the development of biosimilars, ranging from preclinical to phase III trials and postmarketing studies, are already in place in Europe, and the United States Food and Drug Administration (FDA) recently issued draft guidance on biosimilars. A number of biosimilar ESAs and G-CSFs have been approved. Biosimilar monoclonal antibodies are an attractive target for development, with draft guidance from the European Medicines Agency currently under review. Biosimilar medicines may provide cost-effective alternatives to their branded counterparts, potentially benefitting public health by improving access to these medications. It is therefore important to raise awareness of these products among treating physicians. Furthermore, finalization of FDA guidance is important for the development of biosimilar medicines for the US market...

*For a PDF of the full article, click on the link to the left of this introduction.