On 23 October 2023, the US Food and Drug Administration (FDA) approved Celltrion’s Zymfentra (infliximab-dyyb) biosimilar as the first subcutaneous (SC) formulation of infliximab. In...
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FORO LATINOAMERICANO DE ESTA SEMANA
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...
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...
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...
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
FDA issues final guidance on liposome drug products
Posted 27/04/2018
0
On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft guidance...
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