IGBA Calls For ‘Streamlining’ Of Global Biosimilars Process
Points To ‘Limited Value’ Of Efficacy Data; Urges Renewed Education Efforts
The IGBA has called for a “streamlined” global biosimilar development and registration process, with a new policy paper highlighting the limited value of comparative efficacy clinical data at the same time as it urges renewed efforts on educating healthcare professionals.
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With Europe’s biosimilars industry bolstered by a recent statement from the EMA and HMA, as well as the prospect of a more streamlined regulatory pathway in future, Medicines for Europe’s biosimilars chair Isabell Remus and director of biosimilars policy and science Julie Maréchal-Jamil spoke to Generics Bulletin to discuss the path forward.
Speaking exclusively to Generics Bulletin, Indian Pharmaceutical Alliance secretary general Sudarshan Jain says that India’s needs for COVID drugs like favipiravir, remdesivir and tocilizumab will be met “in the near future.” Current IGBA chair Jain also talks about global collaboration by governments and donors for equal vaccine distribution through the Access to COVID-19 Tools Accelerator.
The UK’s implementation of a new national licensing framework for biosimilars has been pushed back from the start of 2021, with the MHRA citing “intense COVID-19 activities” as the cause of an indefinite delay in the consultation process.