Ustekinumab biosimilars Yesintek, Steqeyma, and Otulfi approved by FDA, EMA and Health Canada

Biosimilars/News | Posted 21/01/2025 comments 0
Approved-V13G05

In late 2024 and early 2025, multiple ustekinumab biosimilars, including Yesintek, Steqeyma, and Otulfi, received regulatory approvals in the US, Europe, Canada, and the UK, expanding treatment opt...

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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...

Home/Non‐Biological Complex Drugs
Liposome V15L11

On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft guidance...

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