Author byline as per print journal: Hillel P Cohen, PhD; Caridad Pontes, MD, PhD; Fernando de Mora, MBA, PhD Abstract: The critique of Reilly and McKibben of the meta-analysis conducted by Herndon et al. is factually flawed on several important points. As a result, the conclusions of Reilly and McKibben are not scientifically substantiated. Submitted: […]
Abstract: Reilly and McKibbin oppose the update of FDA interchangeability guidance that does not require clinical switch studies. However, their arguments lack a scientific basis. Submitted: 3 December 2024; Revised: 17 December 2024; Accepted: 18 December 2024; Published online first: 18 December 2024 Comment on the article by Reilly MS and McKibbin RD: Misinformation about interchangeable biosimilars […]
Author byline as per print journal: Michael S Reilly, Esq; Ralph D McKibbin, MD, FACP, FACG, AGAF Abstract: The US biosimilar programme has been highly successful with 53 biosimilars approved by the US Food and Drug Administration (FDA) for 17 reference products. As in most advanced nations of Europe, all FDA-approved biosimilars may be substituted […]
