Axial Spondyloarthritis

• EMA approval · 2026-08-21
  EMA Authorised: Taltz (ixekizumab) — Eli Lilly and Company (Ireland) Limited

  EMA authorised Taltz (ixekizumab) for multiple indications including psoriasis, psoriatic arthritis, axial spondyloarthritis, and juvenile a…

• EMA approval · 2026-07-21
  EMA Authorised: Gobivaz (golimumab) — Advanz Pharma Limited

  Authorised status for Gobivaz (golimumab) by Advanz Pharma Limited for multiple inflammatory diseases, expanding label in Europe.

• EMA approval · 2026-07-15
  EMA Authorised: Rinvoq (upadacitinib) — AbbVie Deutschland GmbH & Co. KG

  Rinvoq (upadacitinib) has been authorised by the EMA for multiple inflammatory diseases including rheumatoid arthritis, psoriatic arthritis,…

• EMA approval · 2026-07-01
  EMA Authorised: Gotenfia (golimumab) — Stada Arzneimittel AG

  European Medicines Agency authorised Gotenfia (golimumab) by Stada Arzneimittel AG for multiple inflammatory diseases including various form…

• EMA approval · 2026-06-12
  EMA Authorised: Fubelv — Biosimilar Collaborations Ireland Limited

  EMA has authorised Fubelv as a biosimilar, with indications across various inflammatory arthritis and psoriasis conditions.

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• EMA approval · 2026-06-09
  EMA Authorised: Rinvoq (upadacitinib) — AbbVie Deutschland GmbH & Co. KG

  EU authorization of Rinvoq (upadacitinib) by AbbVie Deutschland for multiple inflammatory indications including rheumatoid arthritis, psoria…

• EMA approval · 2026-04-23
  EMA Authorised: Taltz (ixekizumab) — Eli Lilly and Company (Ireland) Limited

  EMA authorised Taltz (ixekizumab) from Eli Lilly for psoriasis, psoriatic arthritis, axial spondyloarthritis, and juvenile idiopathic arthri…

• EMA approval · 2026-02-25
  EMA Authorised: Gotenfia (golimumab) — Stada Arzneimittel AG

  The EMA authorised Gotenfia (golimumab) by Stada Arzneimittel AG for multiple inflammatory diseases, including rheumatoid arthritis, juvenil…

• EMA approval · 2026-01-27
  EMA Authorised: Cimzia (certolizumab pegol) — UCB Pharma

  The European Medicines Agency authorised Cimzia (certolizumab pegol) for treatment of rheumatoid arthritis and other inflammatory diseases, …

• EMA approval · 2025-11-20
  EMA Authorised: Gobivaz (golimumab) — Advanz Pharma Limited

  The EMA authorised Gobivaz (golimumab) for multiple inflammatory diseases. Indications include rheumatoid arthritis, juvenile idiopathic art…

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

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

• FDA approval · 2023-06-14
  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 · 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 · 2021-05-28
  FDA Approved: COSENTYX — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2020-05-29
  FDA Approved: TALTZ — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for TALTZ (ixekizumab) by Eli Lilly and Company. This action pertains to a supplemental filing under…

• FDA approval · 2020-03-26
  FDA Approved: TALTZ — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for TALTZ (ixekizumab) from Eli Lilly and Company, indicating an updated or expanded indication …

• FDA approval · 2019-07-23
  FDA Approved: HADLIMA — Original Application (Organon LLC)

  FDA approves Hadlima (adalimumab-bwwd) from Organon as a biosimilar to Humira under the original application BLA761059. It is indicated for …

• FDA approval · 2019-06-13
  FDA Approved: AMJEVITA — Supplemental Application (Nuvaila Limited)

  The FDA approved a supplemental application for AMJEVITA (adalimumab-atto) submitted by Nuvaila Limited.

• FDA approval · 2017-12-01
  FDA Approved: TALTZ — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for TALTZ (ixekizumab) submitted by Eli Lilly and Company, resulting in an expanded label for additi…

• FDA approval · 2010-07-29
  FDA Approved: CIMZIA — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for CIMZIA (certolizumab pegol) submitted by UCB, Inc., resulting in an approved amendment to it…