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.
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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
- EC approval of natalizumab, aflibercept and tocilizumab biosimilars
- EMA recommends approval of first ustekinumab biosimilar Uzpruvo
- FDA approves first interchangeable ustekinumab biosimilar Wezlana
- Alvotech biosimilars: FDA ustekinumab application rejection; adalimumab interchangeability designation re-submission
Research
- 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
- Biosimilar anti-VEGF: transforming retina treatment economics in South Asia
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