Increasing inspections and creating a regulatory pathway for the approval of biosimilars are among the most important areas of the US FDA's fiscal 2011 budget request, US Department of Health and Human Services (HHS) Secretary Ms Kathleen Sebelius says. In testimony before the House Energy and Commerce Committee on 4 February 2010, Ms Sebelius focused on funds included in the budget request for the FDA's efforts to improve medical product safety, including increased inspections and investment in tools to enhance the safety of increasingly complex drugs and biologics.
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Generics
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- 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
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- 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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