On 25 July and 27 June 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of marketing authorizat...
More >EMA recommends approval of four ustekinumab biosimilars: Eksunbi, Fymskina, Otulfi, Steqeyma
Biosimilars/News
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Posted 10/09/2024
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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
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On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft guidance...
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