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On 25 September 2010, China’s State Food and Drug Administration (SFDA) issued new guidance for industry for submission of new drug applications (NDAs) in the common technical document (CTD) format.
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Generics
News
- FDA approves generic teriparatide and levetiracetam
- 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
Research
- Japan’s drug shortage crisis: challenges and policy solutions
- Saudi FDA drug approvals and GMP inspections: trend analysis
- Generic medications in the Lebanese community: understanding and public perception
- Community pharmacists’ understanding of generic and biosimilar drugs: Lebanon case study
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Biosimilars
News
- Canada approves first tocilizumab biosimilar Tyenne
- EMA recommends approval for ustekinumab biosimilar Absimky and Imuldosa
- Canada approves pegfilgrastim biosimilar Armlupeg
- FDA approves fifth ustekinumab biosimilar Imuldosa
Research
- Pertuzumab biosimilar HLX11 meets primary endpoint in Phase 3 comparative clinical study
- Uzpruvo/AVT04 biosimilar in profile
- Long-term real-world safety experience of biosimilars confirms concept of biosimilarity
- Budget impact analysis of Rixathon introduction in Chile for non-Hodgkin lymphoma
General
- Biologicals and biosimilars available for IBD in Canada
- Biosimilar medicines on the Pharmaceutical Benefits Scheme in Australia
- SBR issues consensus on interchangeability of reference products and biosimilars
- Innovative direct purchase agreement sees adalimumab biosimilar prices slashed
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