The US Food and Drug Administration (FDA) announced on 13 November 2014 that it had withdrawn the bioequivalence rating for two generic versions of Janssen Pharmaceutica’s attention deficit hyperactivity disorder drug Concerta (methylphenidate). The agency took the action due to concerns that the drugs may not be therapeutically equivalent to the brand-name drug.
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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
- 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
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- 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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