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.

Sandeep N Athalye

Shivani Mittra

Ankitkumar M Ranpura

Generics and Biosimilars Initiative Journal

The scope of GaBI Journal is broad and of interest and relevance to professionals active in clinical practice, pharmaceutical science and policy. Materials published in GaBI Journal include high quality research reports, literature reviews and case studies, all of which are peer reviewed.    Manuscripts on all aspects of generic and biosimilar medicines, covering areas in clinical, fundamental, technical, manufacturing, bi-processing, economic and social aspects of pharmaceuticals and therapeutics are welcome. In addition, high quality work submitted in other formats, for example, scientific and evidence-based commentaries, may also be considered. In all cases, the emphasis is on quality, originality and knowledge contribution to those involved in health care.    All manuscripts submitted to GaBI Journal are subject to a rigorous peer review process. GaBI Journal plans to be indexed in PubMed within two years, and that indexing will be retrospective.    GaBI Journal is published quarterly from 2012. All articles are published in English.

The GaBI Journal has a broad scope that is of interest and relevance to professionals engaged in clinical practice, pharmaceutical science, and policy. The materials published in the GaBI Journal include high-quality research reports, literature reviews, and case studies, all of which undergo rigorous peer review. We welcome manuscripts on all aspects of generic and biosimilar medicines, covering clinical, fundamental, technical, manufacturing, bioprocessing, economic, and social aspects of pharmaceuticals and therapeutics. Additionally, high-quality work submitted in other formats, such as scientific and evidence-based commentaries, may also be considered. In all cases, we emphasize quality, originality, and the contribution of knowledge to those involved in healthcare. All manuscripts submitted to the GaBI Journal are subject to a thorough peer review process. The GaBI Journal plans to be indexed in PubMed within two years, and this indexing will be retrospective. The GaBI Journal has been published quarterly since 2012, and all articles are published in English.

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Biosimilars drug development: time for a paradigm shift?

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Journal Info

Category	Quartile
PHARMACOLOGY & PHARMACY	4