EMA recommends approval for four denosumab biosimilars: Obodence, Osenvelt, Stoboclo, Xbryk

Biosimilars/News | Posted 15/01/2025 comments 0
Biosimilar biological 800x345 V21L05

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the granting of marketing authorization for four de...

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On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft guidance...

More >