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Health Canada has eliminated Phase III trial requirements for biosimilars, prioritizing analytical studies over large clinical trials to accelerate market access and reduce costs.
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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 first golimumab biosimilars Immgolis and Immgolis Intri
- EMA recommends approval for ranibizumab biosimilar Vislyfa
- FDA approves third interchangeable insulin glargine biosimilar Langlara
- EMA recommends approval for ranibizumab biosimilar Rexatilux
Research
- Biosimilars uptake in Chile: why does it lag behind?
- Biosimilar aflibercept (AVT06) pre-filled syringe promises safer, faster eye injections
- OECD study finds no direct link between advertising rules and biosimilar uptake
- Reaching ESG goals in pharmaceutical development
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