FDA interchangeable biosimilars guidance update on revised approach to switching studies

Guidelines/ | Posted 23/07/2024 comments 0
Interchangeability V18K30

In June 2024, the US Food and Drug Administration (FDA) issued a draft guidance for industry ‘Considerations for Demonstrating Interchangeability with a Reference Product: Update’ [1]. This draft g...

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An update on the joint EMA-HMA statement on interchangeability of biosimilar
Posted 12/05/2023

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On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft guidance...

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