GENERICS AND BIOSIMILARS INITIATIVE JOURNAL
Official Journal of the Generics and Biosimilars Initiative
Volume 5 / Year 2016 / Issue 4
Special Report
The role of European Pharmacopoeia monographs in setting quality standards for biotherapeutic products
Author(s): Emmanuelle Charton, PhD
Page: 174-9Abstract: European Pharmacopoeia (Ph. Eur.) monographs for biotherapeutic products have existed since the 1990s and remain the publicly available standard defining the quality of these medicines. Continued development of such monographs however faces considerable challenges in the current environment. This manuscript addresses what the main challenges are (complexity of biologicals, setting of specifications, relations with […]
Generic medicines entry into the Malaysian pharmaceutical market
Author(s): Omotayo Fatokun, PhD, Professor Mohamed Azmi Hassali, PhD, Professor Mohamed Izham Mohamed Ibrahim, PhD
Page: 180-1Author byline as per print journal: Omotayo Fatokun, PhD; Professor Mohamed Izham Mohamed Ibrahim, PhD; Professor Mohamed Azmi Hassali, PhD Abstract: There are major barriers to generic medicine development and market entry in Malaysia. This mixed method study recommends strategies to increase uptake. Submitted: 25 October 2016; Revised: 15 November 2016; Accepted: 21 November 2016; Published […]
