Introduction: The Association of Southeast Asian Nations (ASEAN) Overview Workshop on GMP for Biologicals and Biosimilars was co-organized with the Generics and Biosimilars Initiative (GaBI). This meeting was intended to improve the understanding of the good manufacture practice (GMP) inspection framework for biological (and biosimilar) drugs among ASEAN countries. Methods: The workshop was held on […]
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 […]
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 […]
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: […]
