Hidradenitis Suppurativa

• 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 · 2023-11-03
  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 · 2023-09-21
  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 · 2023-07-19
  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.

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• 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 · 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 · 2022-07-18
  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 · 2021-12-17
  FDA Approved: YUSIMRY — Original Application (Coherus BioSciences Inc)

  FDA approved YUSIMRY (adalimumab-aqvh) from Coherus BioSciences in an original biologics license application, likely as a biosimilar to adal…

• FDA approval · 2021-10-15
  FDA Approved: ADALIMUMAB-ADBM — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)

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

• FDA approval · 2021-02-24
  FDA Approved: ADALIMUMAB — Supplemental Application (Sandoz Inc)

  FDA approval of a supplemental application for the adalimumab biosimilar ADALIMUMAB-ADAZ from Sandoz Inc.

• FDA approval · 2020-07-06
  FDA Approved: HULIO — Original Application (Biocon Biologics Inc)

  FDA approved HULIO (adalimumab-fkjp) from Biocon Biologics Inc via an original Biologics License Application, a biosimilar to adalimumab. Th…

• 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 · 2018-10-30
  FDA Approved: ADALIMUMAB — Original Application (Sandoz Inc)

  FDA approved the original application for the adalimumab biosimilar ADALIMUMAB-ADAZ from Sandoz Inc. The approval covers the same indication…

• FDA approval · 2018-10-16
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approved a supplemental application for Humira (adalimumab) submitted by Cordavis Limited.

• FDA approval · 2018-03-15
  FDA Approved: AMJEVITA — Supplemental Application (Nuvaila Limited)

  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 · 2016-06-30
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approved a supplemental application for Humira (adalimumab) to Cordavis Limited, authorizing the continued manufacturing/supply of the p…

• FDA approval · 2015-11-23
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  The FDA approved a supplemental application for Humira (adalimumab) filed by Cordavis Limited, indicating regulatory action on a Humira supp…

• EMA approval · 2015-06-26
  First medicine recommended for approval for hidradenitis suppurativa

  The EMA recommends the first medicine for approval to treat hidradenitis suppurativa, marking a landmark for this condition in Europe.

• FDA approval · 2014-09-30
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approved Humira's supplemental application submitted by Cordavis Limited. The approval acts as a supplemental approval to the existing H…