A detailed checklist on the quality, safety and efficacy assessment of biopharmaceuticals was published by Professors Irene Krämer, Roger Tredree and Arnold Vulto in the 2008 EJHP Practice article Points to consider in the evaluation of biopharmaceuticals (Eur J Hosp Pharm Prac. 2008;14(1):73-6). The checklist was then used by Dr Carsten Brockmeyer and Dr Andreas Seidl of Sandoz/Hexal for Binocrit, the results of which were published in Eur J Hosp Pharm Prac. 2009;15(2):34-40.
- Home
-
Generics
News
- FDA approves generic teriparatide and levetiracetam
- 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
Research
- Japan’s drug shortage crisis: challenges and policy solutions
- Saudi FDA drug approvals and GMP inspections: trend analysis
- Generic medications in the Lebanese community: understanding and public perception
- Community pharmacists’ understanding of generic and biosimilar drugs: Lebanon case study
-
Biosimilars
News
- EC approval for three ustekinumab biosimilar: Eksunbi, Fymskina, Otulfi
- FDA approves biosimilars: ustekinumab Otulfi and eculizumab Epysqli
- FDA approves second strength of trastuzumab biosimilar Hercessi
- EMA recommends approval of aflibercept biosimilars Afqlir and Opuviz
Research
- Long-term real-world safety experience of biosimilars confirms concept of biosimilarity
- Budget impact analysis of Rixathon introduction in Chile for non-Hodgkin lymphoma
- Biosimilars in inflammatory bowel disease: are we ready for multiple switches
- Topline results from clinical development programme for candidate biosimilar AVT05 golimumab
- MORE EDITORIAL SECTIONS
- Search
Comments (0)
Post your comment