Author byline as per print journal: Sandeep N Athalye, MS; 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 make way for cost-effective, sustainable development models. In this article, the authors provide a few suggestions that can lead to leaner and faster clinical development of biosimilars in the regulated market, and further across the globe, while not compromising the scientific validity of their development.

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This manuscript has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record.