In the early days, most monoclonal antibody (MAb) therapies required high dosages, as pointed out by Ms Gail Dutton in a Genetic Engineering & Biotechnology News Feature Article on 15 February 2010 (see also Monoclonal antibodies modelling - predictive analytics, Improving monoclonal antibody production - antibody-drug conjugate technology and Modern monoclonal antibody production - focus on quality by design, timelines, cost)
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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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