As part of the Generic Drug User Fee Amendments (GDUFA II) reauthorization recently agreed with industry [1], the US Food and Drug Administration (FDA) has committed to setting up a new approval pathway for drugs with complex active ingredients and formulations, as well as for drug-device combinations.
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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 first natalizumab biosimilar Tyruko for MS
- EMA recommends approval of first natalizumab biosimilar Tyruko for MS
- EMA recommends approval of first aflibercept and tocilizumab biosimilars
- Alvotech: rejection AVT02 in the US and new partnerships with Prolifarma and Advanz Pharma
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