FDA Approves Ustekinumab, Aflibercept, And Filgrastim Biosimilars

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On July 1, Samsung Bioepis Co., Ltd. announced that the FDA has approved PYZCHIVA (ustekinumab-ttwe), a biosimilar referencing STELARA (ustekinumab).
United States Food, Drugs, Healthcare, Life Sciences
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Samsung Bioepis' PYZCHIVA

On July 1, Samsung Bioepis Co., Ltd.  announced that the FDA has approved PYZCHIVA (ustekinumab-ttwe), a biosimilar referencing STELARA (ustekinumab).  PYZCHIVA is approved for the treatment of moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn's disease, and moderately to severely active ulcerative colitis.  According to the press release, PYZCHIVA will be available in the United States beginning on February 22, 2025, pursuant to a settlement and license agreement between Samsung Bioepis and Janssen Biotech Inc.

PYZCHIVA is the third biosimilar referencing STELARA to be approved by the FDA, following  Amgen's WEZLANA (ustekinumab-auub), approved in October 2023, and  Alvotech's and Teva's SELARSDI (ustekinumab-aekn), approved in April 2024.

Formycon's AHZANTIVE

Formycon AG and its licensing partner, Klinge Biopharma GmbH, also  announced on July 1 that the FDA has approved AHZANTIVE (aflibercept-mrbb), a biosimilar referencing EYLEA (aflibercept).  The FDA approved AHZANTIVE for the treatment of patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), Diabetic Retinopathy (DR) and Macular Edema following Retinal Vein Occlusion (RVO).  At the end of 2023, Formycon submitted an application for marketing authorization to the EMA for its aflibercept biosimilar and, according to Formycon, a decision is expected by early 2025.

AHZANTIVE is the third biosimilar referencing EYLEA to be approved by the FDA, following  Biocon's YESAFILI (aflibercept-jbvf) and Samsung Bioepis' OPUVIZ (aflibercept-yszy), both approved in May 2024.

Tanvex's NYPOZI

Tanvex BioPharma, Inc.  also announced on July 1 that the FDA approved its biologics license application for NYPOZI (filgrastim-txid), a biosimilar referencing NEUPOGEN (filgrastim).  NYPOZI is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever.  According to the press release, NYPOZI launched in Canada in January 2024.

NYPOZI is the fourth biosimilar referencing NEUPOGEN to be approved by the FDA, following the approval of Sandoz' ZARXIO in March 2015,  Pfizer's NIVESTYM in October 2018, and Amneal and Kashiv's RELEUKO in March 2022.

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