As part of its efforts to advance the development of generics of complex drugs with the aim of improving patient access to medicines, the US Food and Drug Administration (FDA) announced that it is planning to release new and revised guidance documents for complex generics.
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Generics
News
- 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
- Revlimid (lenalidomide) generics launch across Europe
Research
- 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
- Trajectories of prices in generic drug markets
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Biosimilars
News
- FDA approves Zymfentra and advances for Yuflyma in the US
- EC approval of natalizumab, aflibercept and tocilizumab biosimilars
- EMA recommends approval of first ustekinumab biosimilar Uzpruvo
- FDA approves first interchangeable ustekinumab biosimilar Wezlana
Research
- 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
- Impact of trastuzumab biosimilars use in metastatic HER2-positive breast cancer
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