The US Food and Drug Administration (FDA) has published draft guidance for industry for abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) where the applicant is seeking approval of a new strength of the drug product.
- 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
- Three more biosimilar approvals in Canada in 2023
- EMA recommends approval of first omalizumab biosimilar Omlyclo
- China approves first denosumab copy biological Maiweijian
- EMA recommends approval of first denosumab biosimilar Jubbonti and Wyost
Investigación
- Unveiling key clinical findings for denosumab biosimilar candidates
- 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
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