On 18 June 2009, WHO published a Prequalification Update, informing that a guideline on submission of documentation for prequalification of multisource (generic) has been completed and that Finished Pharmaceutical Products (FPPs) will be approved by Stringent Regulatory Authorities (SRAs). It states that WHO recognises the scientific evaluation of multisource (generic) products by regulatory authorities, which apply similarly stringent standards for quality, safety and efficacy as those recommended by WHO.
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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
- 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
- Impact of e-bidding procurement on generic omeprazole injection prices in Thailand
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Biosimilars
News
- China approves first denosumab copy biological Maiweijian
- EMA recommends approval of first denosumab biosimilar Jubbonti and Wyost
- First denosumab biosimilars approved in Canada and the US
- Dr Reddy's launches bevacizumab biosimilar Versavo in the UK
Research
- Topline results for Polpharma Biologics’ vedolizumab biosimilar candidate
- Comparing biosimilar adoption: Medicare Advantage versus traditional Medicare
- Questioning the need for ethnic sensitivity assessments for biosimilar monoclonal antibodies
- ANVISA's role in biosimilar medicine regulation and innovation promotion
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