Psoriatic Arthritis

• FDA approval · 2023-12-15
  FDA Approved: HULIO — Supplemental Application (Biocon Biologics Inc)

  The FDA approved a supplemental application for HULIO, Biocon Biologics' biosimilar adalimumab (adalimumab-fkJP).

• FDA approval · 2023-11-30
  FDA Approved: ADALIMUMAB — Supplemental Application (CELLTRION USA, Inc.)

  The FDA approved a supplemental Biologics License Application for the adalimumab biosimilar ADALIMUMAB-AATY from Celltrion USA, Inc., allowi…

• FDA approval · 2023-11-21
  FDA Approved: COSENTYX — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Cosentyx (secukinumab) submitted by Novartis Pharmaceuticals, incorporating changes to the a…

• FDA approval · 2023-11-20
  FDA Tentative Approval: TALTZ — Supplemental Application (Eli Lilly and Company)

  The FDA issued tentative approval for a supplemental application for TALTZ (ixekizumab) by Eli Lilly, indicating the submission is approvabl…

• FDA approval · 2023-11-08
  FDA Approved: CIMZIA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for CIMZIA (certolizumab pegol) from UCB, Inc., updating its labeling and/or indications.

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• FDA approval · 2023-11-03
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approves a supplemental application for HUMIRA (adalimumab) to Cordavis Limited, enabling an additional manufacturing/supply pathway for…

• FDA approval · 2023-10-31
  FDA Approved: WEZLANA — Original Application (Nuvaila Limited)

  FDA approved WEZLANA (ustekinumab-auub) from Nuvaila Limited under an original Biologics License Application.

• FDA approval · 2023-10-31
  FDA Approved: WEZLANA — Original Application (Nuvaila Limited)

  This entry documents the original Biologics License Application for WEZLANA, a ustekinumab-AUUB monoclonal antibody developed by Nuvaila Lim…

• FDA approval · 2023-10-20
  FDA Approved: ZYMFENTRA — Original Application (CELLTRION USA Inc.)

  FDA approved ZYMFENTRA (inflximab-dyyb) from Celltrion USA as a biosimilar to infliximab (Remicade), based on demonstration of biosimilarity…

• FDA approval · 2023-10-18
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

  The FDA approved a supplemental application for Enbrel (etanercept) submitted by Immunex Corporation.

• FDA approval · 2023-10-06
  FDA Approved: COSENTYX — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Cosentyx (secukinumab) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2023-09-21
  FDA Approved: ADALIMUMAB — Supplemental Application (CELLTRION USA, Inc.)

  FDA approved a supplemental Biologics License Application for the adalimumab biosimilar ADALIMUMAB-AATY from Celltrion USA, approving its bi…

• FDA approval · 2023-07-24
  FDA Approved: COSENTYX — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Cosentyx (secukinumab) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2023-07-19
  FDA Approved: ADALIMUMAB-ADBM — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)

  The FDA approved a supplemental application for ADALIMUMAB-ADBM, a biosimilar of adalimumab from Quallent Pharmaceuticals Health LLC.

• FDA approval · 2023-06-30
  FDA Approved: ADALIMUMAB-ADBM — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)

  The FDA approved a supplemental application for the adalimumab biosimilar ADALIMUMAB-ADBM from Quallent Pharmaceuticals Health LLC.

• FDA approval · 2023-06-14
  FDA Approved: ABRILADA — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for ABRILADA (adalimumab-afzb) submitted by Pfizer Laboratories Div Pfizer Inc to update the labelin…

• FDA approval · 2023-05-23
  FDA Approved: ADALIMUMAB — Original Application (CELLTRION USA, Inc.)

  FDA approved ADALIMUMAB-AATY from CELLTRION USA, Inc. as a biosimilar to adalimumab under an Original Application for the same indications a…

• FDA approval · 2023-05-18
  FDA Approved: ADALIMUMAB-ADBM — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)

  FDA approved a supplemental application for ADALIMUMAB-ADBM, a biosimilar to adalimumab, from QUALLENT PHARMACEUTICALS HEALTH LLC.

• FDA approval · 2023-04-14
  FDA Approved: ADALIMUMAB — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for adalimumab-adaz, a biosimilar to adalimumab, confirming its regulatory approval for use.

• FDA approval · 2023-03-31
  FDA Approved: YUSIMRY — Supplemental Application (Coherus BioSciences Inc)

  FDA approved a supplemental Biologics License Application for YUSIMRY (adalimumab-aqvh) by Coherus BioSciences, authorizing the biosimilar p…

• FDA approval · 2023-03-06
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for ustekinumab (Stelara) to expand its indications, as requested by Janssen Biotech, Inc.

• FDA approval · 2022-12-13
  FDA Approved: IDACIO — Original Application (Fresenius Kabi USA, LLC)

  FDA approved IDACIO (adalimumab-afcf) from Fresenius Kabi USA, LLC as a biosimilar to adalimumab (Humira) under an original Biologics Licens…

• FDA approval · 2022-11-29
  FDA Approved: JYLAMVO — Original Application (SHORLA ONCOLOGY INC.)

  FDA approved JYLAMVO (methotrexate) under an Original Application from SHORLA ONCOLOGY INC.

• FDA approval · 2022-07-18
  FDA Approved: ADALIMUMAB — Supplemental Application (Sandoz Inc)

  The FDA approved Sandoz's supplemental application for the adalimumab biosimilar ADALIMUMAB-ADAZ. The approval covers multiple inflammatory …

• FDA approval · 2022-06-17
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

  The FDA approved a supplemental application for Enbrel (etanercept) from Immunex Corporation, resulting in labeling changes for the product.…