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The US Food and Drug Administration (FDA) has issued a draft strategy document titled ‘BsUFA III Future Needs in the Development of Interchangeable Products Post-Workshop Strategy Document’, follow...
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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
- EMA recommends approval for biosimilar omalizumab Adcomfo and pertuzumab Pebrilzo
- Canada approves multiple denosumab and ustekinumab biosimilars as global competition grows
- FDA approves Zimrixby (rituximab) and Garzulys (insulin aspart) biosimilars
- EMA recommends approval for biosimilar pegfilgrastim Cavoley
Research
- HHS push to ‘genericize’ biosimilars sparks backlash
- Biosimilar interchangeability: a necessary fix, but not a silver bullet
- EULAR 2025 RA guidelines streamlined as biosimilar expansion reshapes treatment sequencing
- Biosimilars uptake in Chile: why does it lag behind?
General
- FDA publishes draft strategy on interchangeable biosimilars following 2025 public workshop
- Medicines for Europe calls for Biotech Act reforms to address ‘biosimilar void’
- Biosimilars approved in Europe
- SBR issues position statement on safe originator biological/biosimilar interchangeability
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