Biosimilars/News

FDA approves pegfilgrastim biosimilar Udenyca OnBody autoinjector

Biosimilars/News | Posted 06/02/2024

On 26 December 2023, Coherus BioSciences announced the US Food and Drug Administration’s (FDA) approval of Udenyca OnBody, an on-body injector (OBI) presentation of Udenyca (pegfilgrastim-cbqv), a pegfilgrastim biosimilar administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.

FDA approves bevacizumab biosimilar Avzivi

Biosimilars/News | Posted 30/01/2024

On 6 December 2023, the US Food and Drug Administration (FDA) approved China–based manufacturer Bio-Thera Solutions’ bevacizumab biosimilar (BAT1706), Avzivi (bevacizumab-tnjn). This product will be marketed globally by Sandoz.

FDA approves first tocilizumab biosimilar Tofidence

Biosimilars/News | Posted 17/10/2023

On 29 September 2023, the US Food and Drug Administration approved Tofidence (tocilizumab-bavi) as the first biosimilar to Actemra (tocilizumab). Tofidence is first-of-its-kind biosimilar tocilizumab to receive approval in the US.

EC approval of trastuzumab biosimilar Herwenda

Biosimilars/News | Posted 23/01/2024

The European Commission (EC) granted marketing authorization for trastuzumab biosimilar Herwenda on 15 November 2023. The biosimilar of Herwenda is developed by EirGenix, Inc.

EC approval of first ustekinumab biosimilar Uzpruvo

Biosimilars/News | Posted 16/01/2024

On 5 January 2024, the European Commission (EC) granted marketing authorization for the first ustekinumab biosimilar Uzpruvo (AVT04). The biosimilar of Uzpruvo is developed by Iceland-based biosimilar manufacturer Alvotech.

Alvotech: rejection AVT02 in the US and new partnerships with Prolifarma and Advanz Pharma

Biosimilars/News | Posted 03/08/2023

The US Food and Drug Administration (FDA) rejected Alvotech’s biologicals licence application (BLA) for their biosimilar adalimumab AVT02 in June 2023. Alvotech has also formed new partnerships with Prolifarma and Advanz Pharma for proposed biosimilars to Eylea (aflibercept) and Xolair (omalizumab), respectively.

Rinvoq approved to treat Crohn’s disease in Europe

Biosimilars/News | Posted 27/04/2023

On 17 April 2022, AbbVie announced that its Rinvoq (upadacitinib) had received European Commission (EC) approval. It is the first and only oral Janus Kinase (JAK) inhibitor approved to treat moderately to severely active Crohn's disease in adult patients. Rinvoq has the potential to rival AbbVie’s own blockbuster drug, Humira (adalimumab) and its biosimilars for inflammatory autoimmune conditions [1].

EMA recommends approval of ranibizumab biosimilar Rimmyrah

Biosimilars/News | Posted 12/12/2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use announced on 9 November 2023 that it had recommended granting of marketing authorization for Rimmyrah (ranibizumab), a biosimilar that references ophthalmology drug, Lucentis.

FDA approves Zymfentra and advances for Yuflyma in the US

Biosimilars/News | Posted 05/12/2023

On 23 October 2023, the US Food and Drug Administration (FDA) approved Celltrion’s Zymfentra (infliximab-dyyb) biosimilar as the first subcutaneous (SC) formulation of infliximab. In addition, Celltrion USA signed a contract with Ventegra to add Yuflyma (adalimumab-aaty) as a preferred formulary product in both public and private insurance markets.

EC approval of natalizumab, aflibercept and tocilizumab biosimilars

Biosimilars/News | Posted 28/11/2023

In September 2023, the European Commission (EC) granted marketing authorization for the biosimilars of Tyruko (natalizumab), Yesafili (aflibercept), and Tyenne (tocilizumab).