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
- FDA approves biosimilars: ustekinumab Otulfi and eculizumab Epysqli
- EMA recommends approval of aflibercept biosimilars Afqlir and Opuviz
- FDA approves second strength of trastuzumab biosimilar Hercessi
- FDA approves aflibercept biosimilars Enzeevu and Pavblu
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
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