In July 2014, the US Food and Drug Administration (FDA) issued two new draft guidance documents, which outline the agency’s goals for speeding up its handling of regulatory submissions from generics makers.
- 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
- Dr Reddy's launches bevacizumab biosimilar Versavo in the UK
- EMA recommends approval of ustekinumab biosimilar Pyzchiva
- La FDA aprueba el biosimilar intercambiable de adalimumab Simlandi
- EC approval of ranibizumab biosimilar Rimmyrah
Investigación
- Cuestionando la necesidad de evaluaciones de sensibilidad étnica para anticuerpos monoclonales biosimilares
- ANVISA's role in biosimilar medicine regulation and innovation promotion
- Infliximab discontinuation in patients with originator retransition vs biosimilar continuation
- Biological therapies for psoriasis: evaluating durability and persistent benefits
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