Since recombinant human insulin (Humulin) became the first recombinant-protein drug approved by the FDA 25 years ago, nearly 100 recombinant-protein therapeutics including other hormones and monoclonal antibodies, have become part of clinical practice. Though small-molecule drugs are more common than recombinant-protein drugs – only one of the top 200 prescribed drugs of 2006 (on the basis of prescription volume) was a recombinant protein – protein-based therapeutics have been used to treat diabetes and anaemia, as well as relatively rarer conditions, such as rheumatoid arthritis, Gaucher's disease, and multiple sclerosis.
- INICIO
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Genéricos
Novedades
- 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
Investigación
- 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
- Reshaping landscape of Japanese generics market – uncertain future of universal health insurance
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Biosimilares
Novedades
- FDA approves third ustekinumab biosimilar Pyzchiva
- La FDA aprueba el primer biosimilar de eculizumab, Bkemv, para dos enfermedades raras
- EMA recommends approval of biosimilar bevacizumab Avzivi
- EC biosimilar approvals: Omlyclo, Jubbonti/Wyost, and Pyzchiva
Investigación
- Resultados principales del programa de desarrollo clínico del biosimilar candidato AVT05 golimumab
- Eficacia y seguridad del P043 propuesto (Zerafil) frente al omalizumab de referencia en el asma alérgica
- Tocilizumab and pembrolizumab biosimilar advances for Korean firms
- Unveiling key clinical findings for denosumab biosimilar candidates
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