Sartorius Stedim BioOutsource (BioOutsource), a subsidiary of Sartorius Stedim Biotech, has launched a range of ready-to-use assays for testing biosimilarity. The assays are available for biosimilars of Hoffmann–La Roche/Chugai’s rheumatoid arthritis treatment Actemra (tocilizumab), Centocor’s psoriasis treatment Stelara (ustekinumab) and Novartis/Genentech’s age-related macular degeneration drug Lucentis (ranibizumab).
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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
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Biosimilars
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- EC approves golimumab biosimilar Gotenfia and ranibizumab biosimilar Ranluspec
- EMA recommends approval for teriparatide biosimilar Zandoriah
- FDA approves third interchangeable ranibizumab biosimilar Nufymco
- FDA approves Poherdy (first interchangeable pertuzumab) and Armlupeg (pegfilgrastim) biosimilars
Research
- OECD study finds no direct link between advertising rules and biosimilar uptake
- Reaching ESG goals in pharmaceutical development
- What is the future for the US biosimilar interchangeability designation
- Biosimilar clinical efficacy studies: are they still necessary?
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