According to the FDA, each year, Americans save an estimated US$8–10 billion by purchasing generic drugs rather than branded medications. These savings are, of course, the key advantage of generics. However, the very reason for these cost savings—the fact that generic drugs do not have to undergo the large, expensive clinical trials that are required for approval of branded drugs—gives rise to questions about the quality and safety of generics.
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Generics
News
- 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
Research
- Japan’s drug shortage crisis: challenges and policy solutions
- Saudi FDA drug approvals and GMP inspections: trend analysis
- Generic medications in the Lebanese community: understanding and public perception
- Community pharmacists’ understanding of generic and biosimilar drugs: Lebanon case study
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Biosimilars
News
- Canada approves pegfilgrastim biosimilar Armlupeg
- FDA approves fifth ustekinumab biosimilar Imuldosa
- EC approval for three ustekinumab biosimilar: Eksunbi, Fymskina, Otulfi
- FDA approves biosimilars: ustekinumab Otulfi and eculizumab Epysqli
Research
- Long-term real-world safety experience of biosimilars confirms concept of biosimilarity
- Budget impact analysis of Rixathon introduction in Chile for non-Hodgkin lymphoma
- Biosimilars in inflammatory bowel disease: are we ready for multiple switches
- Topline results from clinical development programme for candidate biosimilar AVT05 golimumab
General
- Biosimilar medicines on the Pharmaceutical Benefits Scheme in Australia
- SBR issues consensus on interchangeability of reference products and biosimilars
- Innovative direct purchase agreement sees adalimumab biosimilar prices slashed
- Stelara biosimilar available at US$0 for Accredo patients
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