In February 2020, the US Food and Drug Administration’s (FDA) Office of Generic Drugs released their 2019 Annual report which highlighted the year’s key achievements. The report stated that in 2019, the Office of Generic Drugs (OGD) facilitated 1,014 generic drug final and tentative approvals. This is slightly lower than the 1,021 approvals of 2018 but remains high enough to make a positive contribution to the FDA’s generic drug programme.
- 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
- FDA approves pegfilgrastim biosimilar Udenyca OnBody autoinjector
- La FDA aprueba el biosimilar intercambiable de adalimumab Simlandi
- EC approval of ranibizumab biosimilar Rimmyrah
- FDA BLA updates from Celltrion and Accord
Investigación
- Infliximab discontinuation in patients with originator retransition vs biosimilar continuation
- Biological therapies for psoriasis: evaluating durability and persistent benefits
- Switches between biosimilars and their reference products
- Latin America's biosimilars market: regulatory, institutional, and technological aspects
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