Companies seeking to launch a generic drug are required to submit a dossier to authorities, which does not contain the results of extensive preclinical and clinical testing demonstrating safety and efficacy in the target population, as is the case with novel drugs, but only limited data and evidence demonstrating the fundamental premise that the generic is bioequivalent to its brand-name counterpart.
- 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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