The US Food and Drug Administration (FDA) has finalized revised guidance on good manufacturing practice (GMP) for active pharmaceutical ingredients (APIs).
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Generics
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- 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
- Revlimid (lenalidomide) generics launch across Europe
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Biosimilars
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- New insulin glargine and potential adalimumab interchangeable biosimilars
- Biosimilar advances for Alvotech-Teva and setback for Biocon Biologics
- Advances for Bio-Thera’s secukinumab and mepolizumab copy biologicals
- FDA and EMA file acceptance of Biogen’s tocilizumab biosimilar
Research
- US vs Germany and Switzerland: US biosimilars market lags with higher prices
- Drug survival of adalimumab biosimilars in psoriasis treatment in Spain
- Pegfilgrastim biosimilars in US supportive oncology
- Investigating cell, tissue and gene therapy products and their regulation
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