On 18 December 2014, the European Medicines Agency (EMA) published the new version of its guideline addressing the non-clinical and clinical issues related to similar biological products (biosimilars) containing biotechnology-derived proteins as the active substance. This new guideline will revise the agency’s 2006 overarching guideline on the non-clinical and clinical issues related to similar biological medicinal products.
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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
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Research
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Biosimilars
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Research
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- Comparing biosimilar adoption: Medicare Advantage versus traditional Medicare
- Questioning the need for ethnic sensitivity assessments for biosimilar monoclonal antibodies
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