Australia’s medicines regulatory agency, the Therapeutic Goods Administration (TGA), approved Alvotech/Cipla’s ustekinumab biosimilar, Uteknix, on 11 February 2025.
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FORO LATINOAMERICANO DE ESTA SEMANA
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...
Disruption in the US adalimumab market
Posted 05/06/2024
In April 2024, Evernorth Health Services in the US announced that a biosimila...
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...
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...
Disruption in the US adalimumab market
Posted 05/06/2024
In April 2024, Evernorth Health Services in the US announced that a biosimila...
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
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On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft guidance...
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