EMA announced on 20 January 2012 that it has published a draft guideline on how pharmaceutical companies should test biosimilar medicines containing interferon beta. The draft guideline is released for a four-month public consultation period. Feedback on the draft guideline can be submitted to EMA until the end of May 2012.
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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
- 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
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- Canada approves pegfilgrastim biosimilar Pexegra
- Insulin aspart and denosumab biosimilars approved in US
- FDA approves tocilizumab biosimilar Avtozma
- January 2025 biosimilar approvals in Europe
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