EMA concept paper towards a tailored clinical approach in biosimilar development

Policies & Legislation/ | Posted 09/02/2024 comments 0
Concept Paper V13G05

In November 2023, EMA’s Committee for Medicinal Products for Human Use (CHMP) published a 'Concept paper for the development of a reflection paper on a tailored clinical approach in biosimilar deve...

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Guidance V13F21
WHO’s revised guideline to safe and effective biosimilar products
Posted 24/02/2023

The review article published by Kang H-N et al. in 2023 presents the key upda...

Interchangeability V18K30
UK updates guidance to allow biosimilars interchangeability
Posted 13/01/2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) updated its 20...

Guidelines for the regulation of biologicals, biosimilars and radiopharmaceuticals in Brazil
Posted 01/12/2022

ANVISA (Agência Nacional de Vigilância Sanitária), the National Health Survei...

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On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft guidance...

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