Search results for Meeting Report

First Asia-Pacific educational workshop on non-biological complex drugs (NBCDs), Kuala Lumpur, Malaysia, 8 October 2013

Author byline as per print journal: Professor Philip D Walson, MD, Professor Stefan Mühlebach, PhD, Beat Flühmann, PhD Introduction: In recent years a new category of medicinal products, the non-biological complex drugs (NBCDs) emerged. They are distinct from both the small molecules and the biological therapeutics by being composed of non-homomolecular large structures, some of […]

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The authorization of non-biological complex drugs (NBCDs) follow-on versions: specific regulatory and interchangeability rules ahead?

Author byline as per print journal: Professor Stefan Mühlebach, PhD, Professor Arnold Vulto, PharmD, PhD, Jon SB de Vlieger, PhD, Vera Weinstein, PhD, Beat Flühmann, PhD, Vinod P Shah, PhD Introduction: Besides biologicals, a new class of complex drugs – non-biological complex drugs (NBCDs), e.g. liposomes, iron carbohydrate products and glatiramoids – has emerged. Originator […]

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2nd MENA Stakeholder Meeting on Biosimilars 2018 – Report

Introduction: The number of biosimilars, or similar biotherapeutic products, is expanding rapidly worldwide. A further 12 blockbuster biologicals are set to add to this number by 2020. Agreement about the best practices for the regulation, use, interchangeability and pharmacovigilance of biosimilars is lacking in many countries including in the Middle East and North Africa (MENA).Methods: […]

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