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 […]
Abstract: The US Food and Drug Administration (FDA) proposed eliminating the distinction between biosimilars and interchangeable biosimilars with the stated aim of aligning with European policy and enhance biosimilar uptake. However, this move is misguided as it would result in widespread generic-style automatic substitution at the pharmacy level; which is rare in Europe. Physician confidence […]
Author byline as per print journal: Michael S Reilly, Esq; Gail Attara; Ralph D McKibbin, MD, FACP, FACG, AGAF; Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP Introduction: Biosimilars are now key players in the global drugs market offering potentially more affordable treatment options with similar safety and efficacy. However, there are concerns about non-medical […]
Abstract: Biosimilars are highly similar versions of reference biological products, some with the potential to be deemed ‘interchangeable’ by medicines regulatory bodies, such as the US Food and Drug Administration. Biosimilar patent litigation continues to evolve as biosimilars enter new global markets. This manuscript is the second part of a manuscript that took a look […]
