Menu

High mannose glycans in biosimilars and their pharmacokinetic impact

Biosimilars/Research | Posted 19/05/2023 comments 0
Pharmacokinetics 1 V13K15

A study conducted by Welch J et al. assessed the measurement, evaluation and potential for high mannose glycans to impact the pharmacokinetic (PK) profile of biosimila...

More >
FORO LATINOAMERICANO DE ESTA SEMANA
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...

ANVISA V22A14
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

FDA issues final guidance on liposome drug products

Posted 27/04/2018 comments 0

On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft guidance...

More >