Guidelines

Comments criticize FDA guidance on insulin biosimilars

Home/Guidelines | Posted 20/03/2020

Eli Lilly and Novo Nordisk have submitted critical comments on the US Food and Drug Administration’s (FDA) draft guidance on insulin biosimilars, which suggests that immunogenicity testing may not be necessary for all products.

FDA issues new rule on definition of term ‘biological product’

Home/Guidelines | Posted 06/03/2020

The US Food and Drug Administration (FDA) announced on 20 February 2020 that it had issued a final rule on the definition of the term ‘biological product’.

FDA issues new guidance for biosimilar user fees

Home/Guidelines | Posted 28/02/2020

The US Food and Drug Administration (FDA) has issued final guidance on the structure of the agency’s user fee programme under the Biosimilar User Fee Act of 2017 (BsUFA II).

FDA issues draft guidance on labelling and advertising of biologicals

Home/Guidelines | Posted 21/02/2020

The US Food and Drug Administration (FDA) has issued a draft guidance on labelling and advertising of biologicals, including biosimilars.

FDA issues draft guidance on licensing biosimilars for fewer indications

Home/Guidelines | Posted 14/02/2020

The US Food and Drug Administration (FDA) announced in February 2020 that it had issued draft guidance on getting approval for biosimilars for just some of the approved indications of the originator biological.

UK medicines agency releases no-deal Brexit guidance

Home/Guidelines | Posted 10/01/2020

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on how to source comparator products for generic drug applications in the event of a no-deal Brexit.

FDA issues updated guidance on implementing GDUFA II

Home/Guidelines | Posted 13/12/2019

The US Food and Drug Administration (FDA) has revised and replaced its draft guidance on implementing the Generic Drug User Fee Amendments of 2017 (GDUFA II).

Health Canada publishes biosimilars fact sheet

Home/Guidelines | Posted 06/12/2019

Health Canada has published a fact sheet on biosimilars, which aims to provide a comprehensive overview on a number of issues concerning biosimilars.

FDA issues draft guidance for insulin biosimilars

Home/Guidelines | Posted 29/11/2019

The US Food and Drug Administration (FDA) announced on 25 November 2019 that it had issued draft guidance on immunogenicity considerations for insulin biosimilars.

EC publishes biosimilar information for healthcare professionals in 23 languages

Home/Guidelines | Posted 08/11/2019

The European Commission (EC) and the European Medicines Agency (EMA) have published an information guide on biosimilars aimed at healthcare professionals in 23 languages.