Author Archives: Tina Morris

Surveying the Biosimilars Regulatory Landscape

BPI’s history coincides with that of biosimilars development. Although nonpeptide biosimilar products did not begin receiving commercial authorization until the 2010s, health authorities and drug makers already had been exploring the complex concept of biosimilarity. In the May issue of BPI’s first volume, Theresa L. Gerrard (then an independent consultant who also had been director of the Division of Cytokine Biology at the US Food and Drug Administration Center for Biologics Evaluation and Research, FDA CBER) wrote: The potential for…