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: Sandeep N Athalye, MBBS, MD; Shivani Mittra, MPharm, PhD; Ankitkumar M Ranpura, MD Abstract: The sky-rocketing cost of developing biosimilars is becoming a shared deterrent for biosimilar developers. The regulatory requirements for biosimilars must see a natural evolution and a paradigm shift towards removing inefficiencies in clinical designs to […]
Abstract: Systematic clinical switch studies to demonstrate interchangeability of biosimilars are required in some jurisdictions while theoretical considerations and current clinical data question the feasibility and relevance of such studies. Submitted: 27 November 2021; Revised: 15 December 2021; Accepted: 15 December 2021; Published online first: 28 December 2021 Biosimilars have been used for 15 years […]
