European Pharmacopoeia (Ph. Eur.) monographs for biologicals 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 and the value and utility of these monographs have been questioned in recent years. What such challenges are and how they can be overcome is discussed by Head of Division of the European Pharmacopoeia Department at the EDQM, Dr Emmanuelle Charton, in a GaBI Journal paper [1].
- Home
-
Generics
News
- US generics launch and approval for Dr Reddy’s and Lupin
- Five Chinese companies join UN’s MPP for Covid-19 medicines
- South Korean companies to make generic Bridion and COVID-19 drugs
- Revlimid (lenalidomide) generics launch across Europe
Research
- Evaluation of pharmaceutical equivalency of manufactured generic drugs in UAE
- New insights into the amount of R & D for new uses of generic drugs
- Pricing and reimbursement of medicines in Canada
- Medicines pricing conditions in Italy and Brazil: comparison of regulations
-
Biosimilars
News
- China approves tocilizumab copy biological BAT1806
- FDA accepts application for denosumab biosimilar GP2411
- EMA accepts application for ustekinumab biosimilar AVT04
- Ranibizumab biosimilar Ximluci and Amelivu to launch in the UK and South Korea
Research
- A global overview of manufacturers of follow-on biologicals
- Study supports increased development of insulin biosimilars
- Malaysian hospital pharmacists’ perspective on and role in promoting biosimilars use
- Survey demonstrates US pharmacist biosimilar knowledge gaps
- MORE EDITORIAL SECTIONS
- Search
Post your comment