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
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- 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
- 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
- Reshaping landscape of Japanese generics market – uncertain future of universal health insurance
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Biosimilars
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- Canada approves trastuzumab Adheroza and ustekinumab Steqeyma biosimilars
- EMA recommends approval of ranibizumab, rituximab and trastuzumab biosimilars
- COFEPRIS approves bevacizumab Bhava and trastuzumab Mamitra biocomparables
- EMA recommends approval of four ustekinumab biosimilars: Eksunbi, Fymskina, Otulfi, Steqeyma
Research
- Long-term real-world safety experience of biosimilars confirms concept of biosimilarity
- Budget impact analysis of Rixathon introduction in Chile for non-Hodgkin lymphoma
- Biosimilars in inflammatory bowel disease: are we ready for multiple switches
- Topline results from clinical development programme for candidate biosimilar AVT05 golimumab
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