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International Clinical Trials

Role of Biosimilars in Clinical Trial Supplies

Since 2006, the growth in the biosimilar market has been significant. There are no meaningful clinical differences between the originator medicine and the biosimilar in terms of safety and effectiveness, and biosimilars are typically less expensive than the originator.

These factors have led to a growing popularity in biosimilars to help bring safe and effective drugs to market at an affordable price.

What Are Biosimilars and Biological Medicines?

A biosimilar is a highly similar version of an already authorised, original biological medicinal product. Because biosimilars are made in living organisms, minor structural differences may exist between a biosimilar and its reference medicine, but these differences are not clinically meaningful (1-2). Biosimilars are important because they encourage competition and lower prices, thereby enhancing patient access to biologic treatments, and relieving pressure on healthcare budgets (3-4).

To understand the key features of biosimilars, you should first consider the class of medicines that they are part of biological medicines. Biological medicines, or biologicals, contain active substances that are derived from a biological source, for example, from living cells or organisms. Biologicals are used in clinical trials and are crucial in the treatment of many serious conditions such as cancers, diabetes, and autoimmune disease. Eight of the top ten selling pharmaceuticals are biologicals.

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About the Author

Vanessa Dekou is a Scientist-Entrepreneur, and Managing Director of Clinical Services International (CSI) a leading provider of clinical trial supplies to the biopharmaceutical industry. Vanessa started her career as a research associate at Scotland Yard, then joined LGC Group. Subsequently, she joined IQVIA, and worked with some of the largest biopharma and biotechnology companies. She has extensive experience in drug development from preclinical to registration and commercialisation strategies, and has secured product registration for several orphans and first-in-class drugs. Vanessa has a PhD in Cardiovascular Genetics from University College London, UK, and a Master's in Market Access from the University of Lyon, France.
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Stevanato Group signs an agreement with Nelson Labs to provide best-in-class Extractables and Leachables testing services at its US Technology Excellence Center

Piombino Dese, Padua Italy and Salt Lake City, USA September 2, 2020: Italian-based Stevanato Group, a leading producer of glass primary packaging and provider of integrated services for combination products, and Nelson Laboratories, LLC, a global provider of lab testing and expert advisory services signed today a partnership agreement that will provide Extractables and Leachables testing at SG US Technology Excellence Center in Boston, MA.
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