News

• US generic approvals for Acrux and Cipla
• Natco cancer generic approval and advances for Lannett asthma and diabetes products
• FDA approval for schizophrenia and HIV generics from Zydus Cadila and Lupin
• Zydus Cadila and Sandoz generics approvals in North America

Research

• The generics market in Brazil
• Laws on packaging, substitution and prescription of generics in Brazil
• Legal requirements on equivalence studies for generics in Brazil
• Backlog of drug patents in Brazil

General

• Generics applications under review by EMA – July 2021
• A European pharmaceutical strategy promoting generics and biosimilars
• Use of generics increases during the COVID-19 pandemic in Mexico
• COVID-19 IP waivers could lead to global pharma patent changes

News

• China approves sintilimab plus bevacizumab copy biological Byvasda
• EMA recommends approval of Samsung Bioepis/Biogen’s ranibizumab biosimilar Byooviz
• Canada approves rituximab biosimilar Riabni
• Canada approves pegfilgrastim biosimilar Nyvepria

Research

• What drives negative perceptions of biosimilars?
• Clinical trials begin for ustekinumab biosimilars
• Switching to biosimilars safe and effective in IBD patients
• Biosimilars in Spain: balance between innovation and health public expenditure

General

• Biosimilars as a sustainable alternative for complex diseases
• PANLAR issues consensus statement on biosimilars
• Diferencias entre los medicamentos genéricos y los biosimilares
• Biosimilar pipelines for South Korean firms: LG Chem and GC Pharma

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