Questioning the need for ethnic sensitivity assessments for biosimilar monoclonal antibodies

Biosimilars/Research | Posted 27/03/2024 comments 0
04 AA010978

A GaBIJ perspective article entitled ‘Ethnic sensitivity assessments in biosimilar monoclonal antibodies clinical development programmes: necessary or not?’, was published by a group of a...

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FORO LATINOAMERICANO DE ESTA SEMANA
24-AA011041
An update on the joint EMA-HMA statement on interchangeability of biosimilar
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On 21 April 2023, the European Medicines Agency (EMA) and the Heads of Medicines Agenci...

Regulation V13H16
Inflation Reduction Act explained
Posted 24/07/2023

The US Assistant Secretary for Planning and Evaluation’s (ASPE) ‘Medicare Part B drugs:...

Switching V19A17
Canada’s Prince Edward Island adopts biosimilars switching policy
Posted 07/11/2023

Canada’s Prince Edward Island (PEI) becomes the 11th Canadian jurisdiction to...

Home/Non‐Biological Complex Drugs
Liposome V15L11

On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft guidance...

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