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On 26 June 2014, the European Medicines Agency (EMA) published the new version of its biosimilars quality guideline, which will revise the agency’s 2005 overarching guideline on the quality of similar biological medicinal products. The guideline will come into effect by the end of the year.
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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
- FDA approves Poherdy (first interchangeable pertuzumab) and Armlupeg (pegfilgrastim) biosimilars
- EMA recommends approval for insulin glargine biosimilar Ondibta and denosumab biosimilar Osqay
- FDA approves denosumab biosimilars Osvyrti and Jubereq, Boncresa and Oziltus
- FDA approves aflibercept biosimilar Eydenzelt and label expansion for adalimumab biosimilar Yuflyma
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