Drugs / FKB327
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed psoriasis-related juvenile idiopathic arthritis 1 milestone | |||||
| Filed | US (FDA) | Hyrimoz | psoriasis-related juvenile idiopathic arthritis | 2022-07-21 | “accepted for review its Supplemental Biologics License Application (sBLA) for a high concentration formulation of 100 mg/mL (HCF) of its biosimilar Hyrimoz®” sandoz.com ↗ |
| Filed rheumatoid arthritis 1 milestone | |||||
| Filed | EU (EMA) | Hyrimoz | rheumatoid arthritis | 2017-05-18 | “on May 18, 2017, the European Medicines Agency (EMA) has accepted for review the Marketing Authorisation Application (MAA) for FKB327” kyowakirin.com ↗ “Recently, the European Medicines Agency also accepted the application for Sandoz proposed Hyrimoz HCF.” sandoz.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02405780 | Jun 2015 → Jan 2018 | rheumatoid arthritis | Fujifilm Kyowa Kirin Biologics Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02260791 | Dec 2014 → Jul 2016 | rheumatoid arthritis | Fujifilm Kyowa Kirin Biologics Co., Ltd. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 20
| Date | Issuer | Release |
|---|---|---|
| 2026-09-16 | Shanghai Henlius Biotech | Regulatory Henlius HANDAYUAN Received DRAP Approval in Pakistan henlius.com ↗
Getz Pharma (Private) Limited (Getz Pharma) has received the relevant registration certificates from the Drug Regulatory Authority of Pakistan (DRAP) for the approval of Henlius’ self-developed and manufactured adalimumab biosimilar HANDAYUAN under the trade name Adaliget® |
| 2024-05-22 | Shanghai Henlius Biotech | Regulatory The Supplemental Applications of HANDAYUAN(adalimumab injection) for the New Indications Approved by the NMPA henlius.com ↗
have been approved by the National Medical Products Administration (NMPA) |
| 2024-02-29 | Shanghai Henlius Biotech | Regulatory Henlius Adalimumab Biosimilar Received sNDA Acceptance Notification from the NMPA henlius.com ↗
the supplemental new drug applications (sNDAs) of its adalimumab biosimilar HANDAYUAN for the treatment of polyarticular juvenile idiopathic arthritis，pediatric plaque psoriasis and other indications have been accepted by the National Medical Products Administration (NMPA) |
| 2022-10-25 | The Medicines Company | Regulatory Novartis maintient sa dynamique de croissance et confirme les prévisions de l’exercice 2022 pour le Groupe novartis.com ↗
La FDA a accepté de revoir la demande de licence supplémentaire d’un biologique (sBLA) pour la formulation à forte concentration du Hyrimoz (adalimumab-adaz). |
| 2022-06-17 | Novartis Pharmaceuticals | Regulatory Sandoz Application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA novartis.com ↗
Sandoz, a global leader in generic and biosimilar medicines, today announced that the European Medicines Agency (EMA) has accepted the application for high concentration formulation 100 mg/mL (HCF) of its biosimilar Hyrimoz ® (adalimumab) for regulatory review. |
| 2021-12-28 | Shanghai Henlius Biotech | Results Phase 3 clinical results of adalimumab biosimilar 汉达远® in psoriasis patients, published in an international journal Advances in Therapy henlius.com ↗
The results showed that 汉达远® was highly similar to the reference adalimumab in terms of efficacy, safety and immunogenicity. |
| 2020-12-07 | Shanghai Henlius Biotech | Regulatory Henlius Adalimumab Biosimilar 汉达远® Approved by NMPA henlius.com ↗
The approval of this product marks the expansion of the Company's commercial pipeline into the field of autoimmune diseases and the scope of patients that can benefit from Henlius products is further broadened. |
| 2020-10-29 | Shanghai Henlius Biotech | Results The Results of the Phase 3 Study of Henlius’ Adalimumab Biosimilar HLX03 Presented on EADV 2020 henlius.com ↗
The results show that the efficacy of HLX03 for moderate to severe plaque psoriasis is equivalent to that of the reference adalimumab injection, and it is also similar to the reference drug in terms of safety, immunogenicity and pharmacokinetics. |
| 2019-07-04 | Shanghai Henlius Biotech | Results Henlius Has Completed the Phase 3 Study of Its Adalimumab Injection HLX03 henlius.com ↗
The results from the Phase 3 study of HLX03 showed the similarity in efficacy of HLX03 compare to reference drug for the treatment of moderate-to-severe plaque psoriasis. |
| 2019-06-17 | Shanghai Henlius Biotech | Results Henlius Presented Data of Two Anti-inflammatory Candidates at EULAR 2019 henlius.com ↗
In the HLX03-HV01 study, HLX03 met all the pre-defined PK, safety and immunogenicity endpoints in healthy individuals. |
| 2019-06-14 | Novartis Pharmaceuticals | Results New Sandoz biosimilar adalimumab data confirms switching from reference biologic has no impact on safety or efficacy novartis.com ↗
Data show switching to Hyrimoz ® (biosimilar adalimumab) from the reference medicine provides sustained efficacy with no new safety concerns in patients with moderate-to-severe rheumatoid arthritis[1] |
| 2019-01-24 | Shanghai Henlius Biotech | Regulatory Henlius Adalimumab Received Acceptance of New Drug Application henlius.com ↗
Henlius has recently received a New Drug Application (NDA) acceptance from the National Medical Products Administration (NMPA) for its adalimumab HLX03, a recombinant anti-TNF-α human monoclonal antibody injection. |
| 2018-11-29 | Shanghai Henlius Biotech | Results Henlius Completed Data Analysis of the Phase 1 Study for Its HLX03 henlius.com ↗
The study demonstrated similarity in pharmacokinetic, safety and immunogenicity profiles between HLX03 and Humira (the clinical data are sourced from our final CSR). |
| 2018-09-20 | Kyowa Kirin, Inc. | Regulatory Mylan and Fujifilm Kyowa Kirin Biologics Receive European Marketing Authorization for Hulio®, Biosimilar Adalimumab kyowakirin.com ↗
MylanN.V. (NASDAQ: MYL) and Fujifilm Kyowa Kirin Biologics Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for Hulio® (Product Code:FKB327), a biosimilar to AbbVie's Humira® (adalimumab), for all indications. |
| 2018-07-27 | Kyowa Kirin, Inc. | Regulatory Mylan and Fujifilm Kyowa Kirin Biologics Announce Positive CHMP Opinion for Hulio™, Biosimilar Adalimumab kyowakirin.com ↗
CHMP's decision to recommend the approval of Hulio, a biosimilar to adalimumab, represents a positive step to bring this treatment to patients and demonstrates the strength of our collaboration with Fujifilm Kyowa Kirin Biologics. |
| 2018-06-01 | Novartis Pharmaceuticals | Regulatory Sandoz receives positive CHMP opinion for proposed biosimilar adalimumab novartis.com ↗
The CHMP opinion recommends the proposed Sandoz biosimilar adalimumab for treatment of all indications of its reference medicine |
| 2018-01-16 | Novartis Pharmaceuticals | Regulatory Sandoz regulatory submission for proposed biosimilar adalimumab accepted by FDA novartis.com ↗
Sandoz, a Novartis division and the global leader in biosimilar medicines, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA), submitted under the 351 (k) pathway, for proposed biosimilar adalimumab to the reference medicine, Humira ® *. |
| 2017-09-14 | Novartis Pharmaceuticals | Results Sandoz proposed biosimilar adalimumab matches reference biologic in terms of efficacy and safety in long-term study novartis.com ↗
Data from a long-term study of patients continuously treated with the proposed biosimilar or the reference medicine show that efficacy and safety profiles of the two medicines match throughout 51 weeks of treatment in patients with moderate-to-severe chronic plaque psoriasis[1]. |
| 2017-05-22 | Kyowa Kirin, Inc. | Regulatory FUJIFILM KYOWA KIRIN BIOLOGICS Announces Marketing Authorisation Application for FKB327 Accepted for Review by European Medicines Agency kyowakirin.com ↗
the European Medicines Agency (EMA) has accepted for review the Marketing Authorisation Application (MAA) for FKB327, an adalimumab biosimilar candidate |
| 2016-10-19 | Kyowa Kirin, Inc. | Results Fujifilm Kyowa Kirin Biologics Announces Positive Result in Primary Endpoint from Phase 3 Study of Adalimumab Biosimilar, anti-TNF-α Monoclonal Antibody kyowakirin.com ↗
The primary endpoint (ACR20 response*3), evaluating the disease activity of rheumatoid arthritis after 24 weeks of treatment, met the prespecified criteria of equivalence. |
All press releases naming this drug 21 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | FKB327 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02405780 ↗ |
| Known as | adalimumab | “FKB327, an adalimumab biosimilar, versus the reference product: results of a randomized, Phase III, double-blind study, and its open-label extension.” PMID 31831079 ↗ Dec 2019 |
| Modality | Protein / enzyme biologic | “FKB327, an adalimumab biosimilar, versus the reference product: results of a randomized, Phase III, double-blind study, and its open-label extension.” PMID 31831079 ↗ Dec 2019 |
| Route | Subcutaneous | “subcutaneous injection” NCT02260791 ↗ |