FDA issues draft guidance on biosimilars and interchangeable biosimilars labelling

Guidelines/ | Posted 22/09/2023 comments 0
Label prescription drugs

The US Food and Drug Administration (FDA) announced on 15 September 2023, the availability of a draft guidance for industry entitled ‘Labeling for Biosimilar and Interchangeable Biosimilar Products...

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On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft guidance...

More >