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Biosimilars or follow-on biologics (FOBs) are biopharmaceuticals that, unlike small molecule generic products, are copies of larger, much more complex proteins. As such, data generated from one biopharmaceutical cannot be extrapolated to another. Unlike small molecule generics, FOBs require a full developmental programme, albeit smaller than for an originator product. This has been recognized by European regulatory authorities and it is becoming clear that accelerated processes for FOB marketing approval are not feasible.
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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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