EC approval for three ustekinumab biosimilar: Eksunbi, Fymskina, Otulfi

Biosimilars/News | Posted 05/11/2024 comments 0
Turkey 2016 COVER V16E31DG

The European Commission (EC) granted marketing authorization for three ustekinumab biosimilars: Samsung Bioepis’ Eksunbi on 12 September 2024; Formycon’s Fymskina, and Fresenius Kabi’s&nb...

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FORO LATINOAMERICANO DE ESTA SEMANA
01 AA007239
FDA proposal to remove biosimilar interchangeability status in FY25
Posted 12/06/2024

In a major shift in regulatory policy, the US Food and Drug Administration (FDA)&n...

Pay for Delay DrugsMoneyGeneric V13F21
Disruption in the US adalimumab market
Posted 05/06/2024

In April 2024, Evernorth Health Services in the US announced that a biosimila...

TNFa Crystal Structure V18K17
Topline results from clinical development programme for candidate biosimilar AVT05 golimumab
Posted 23/07/2024

In April and June 2024, Icelandic biosimilar company Alvotech announced promising resul...

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Liposome V15L11

On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft guidance...

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