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.
- INICIO
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Genéricos
Novedades
- 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
Investigación
- Generic medications in the Lebanese community: understanding and public perception
- Community pharmacists’ understanding of generic and biosimilar drugs: Lebanon case study
- Reshaping landscape of Japanese generics market – uncertain future of universal health insurance
- Impact of e-bidding procurement on generic omeprazole injection prices in Thailand
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Biosimilares
Novedades
- China approves first denosumab copy biological Maiweijian
- EMA recommends approval of first denosumab biosimilar Jubbonti and Wyost
- First denosumab biosimilars approved in Canada and the US
- Dr Reddy's launches bevacizumab biosimilar Versavo in the UK
Investigación
- Topline results for Polpharma Biologics’ vedolizumab biosimilar candidate
- Comparing biosimilar adoption: Medicare Advantage versus traditional Medicare
- Cuestionando la necesidad de evaluaciones de sensibilidad étnica para anticuerpos monoclonales biosimilares
- ANVISA's role in biosimilar medicine regulation and innovation promotion
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