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FDA/EMA current thinking on totality of evidence for development of biosimilars
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Journal of Bioanalysis & Biomedicine

ISSN: 1948-593X

Open Access

FDA/EMA current thinking on totality of evidence for development of biosimilars


7th European Biosimilars Congress

May 15-16, 2017 Munich, Germany

Kamali Chance

QuintilesIMS, USA

Posters & Accepted Abstracts: J Bioanal Biomed

Abstract :

The regulatory landscape for the development of biosimilars in the US and EU is dynamic as many of the guidance issued by European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have undergone revisions based on experience gained through review and approval of biosimilars for the respective regions. Sponsors have indeed demonstrated that quality (safe and effective) biosimilars can be developed using state of the art analytical and biological methods. This session is designed to provide current status of biosimilar guidelines in the US and EU. The focus will be to identify major updates in order to help sponsors navigate through the complex requirements for the regulatory approval of biosimilars in the US and EU.

Biography :

Email: kamali.chance@quintilesIMS.com

Google Scholar citation report
Citations: 3099

Journal of Bioanalysis & Biomedicine received 3099 citations as per Google Scholar report

Journal of Bioanalysis & Biomedicine peer review process verified at publons

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