Biosimilars/News

FDA approves interchangeable adalimumab biosimilar Simlandi

Biosimilars/News | Posted 11/03/2024

On 23 February 2024, the US Food and Drug Administration (FDA) approved Alvotech and Teva’s Simlandi (adalimumab-ryvk) injection as an interchangeable biosimilar to AbbVie’s Humira (adalimumab).

EC approval of ranibizumab biosimilar Rimmyrah

Biosimilars/News | Posted 07/03/2024

The European Commission (EC) granted marketing authorization for ranibizumab biosimilar Rimmyrah on 5 January 2024. The biosimilar was developed by Qilu Pharma.

FDA BLA updates from Celltrion and Accord

Biosimilars/News | Posted 29/02/2024

In January 2024, Celltrion submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for CT-P47, a biosimilar candidate of the reference product Actemra ( tocilizumab). In addition, Accord BioPharma, announced that the FDA accepted its BLA for DMB-311, a biosimilar to Stelara (ustekinumab), approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. 

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.

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.

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).