drugset
Drugs / FKB327
last change Jul 2023 re-read 2 minutes ago

FKB327

also known as HLX03 · adalimumab · Adalimumab biosimilar · Hyrimoz

Protein / enzyme biologic targets TNF

Developed for
rheumatoid arthritis · psoriasis · spondyloarthropathy
Investigated by
Fujifilm Kyowa Kirin Biologics Co., Ltd. · Shanghai Henlius Biotech · Novartis Pharmaceuticals

Trials 5 · a red edge is where a trial was stopped

today NCT03906136 · Ph 3 NCT03316781 · Ph 3 NCT03357939 · Ph 1 NCT02405780 · Ph 3 NCT02260791 · Ph 3
2015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT03357939 Jan 2017 → Sep 2018 immune system disorder Shanghai Henlius Biotech Completed No outcome recorded
Phase 34 trials
Phase 3 NCT03906136 Jun 2019 → Feb 2022 spondyloarthropathy Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT03316781 Oct 2017 → Jul 2018 psoriasis Shanghai Henlius Biotech Completed No outcome recorded
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 No outcome recorded

Press releases naming this drug 16 releases

DateIssuerRelease
2023-07-01 Novartis Pharmaceuticals Sandoz to launch Hyrimoz® (adalimumab-adaz) high-concentration formulation, marking Sandoz entrance into US immunology space novartis.com ↗
2023-04-03 Novartis Pharmaceuticals Sandoz receives approval by European Commission for Hyrimoz® (adalimumab) high-concentration formulation novartis.com ↗
2023-03-21 Novartis Pharmaceuticals Sandoz receives US FDA approval for biosimilar Hyrimoz® (adalimumab-adaz) high-concentration formulation novartis.com ↗
2023-01-30 Novartis Pharmaceuticals Sandoz receives positive CHMP opinion for citrate-free high concentration formulation of adalimumab biosimilar novartis.com ↗
2022-07-21 Novartis Pharmaceuticals Sandoz Supplemental Biologics License Application accepted by US FDA for biosimilar Hyrimoz® (adalimumab-adaz) high concentration formulation (HCF) novartis.com ↗
2022-06-17 Novartis Pharmaceuticals Sandoz Application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA novartis.com ↗
2019-06-14 Novartis Pharmaceuticals New Sandoz biosimilar adalimumab data confirms switching from reference biologic has no impact on safety or efficacy novartis.com ↗
2018-10-31 Novartis Pharmaceuticals Sandoz receives US FDA approval for biosimilar Hyrimoz(TM) (adalimumab-adaz) novartis.com ↗
2018-10-11 Novartis Pharmaceuticals Sandoz announces global resolution of biosimilar adalimumab patent disputes, securing patient access novartis.com ↗
2018-07-27 Novartis Pharmaceuticals Sandoz receives European Commission approval for biosimilar Hyrimoz® (adalimumab) novartis.com ↗
2018-06-01 Novartis Pharmaceuticals Sandoz receives positive CHMP opinion for proposed biosimilar adalimumab novartis.com ↗
2018-01-16 Novartis Pharmaceuticals Sandoz regulatory submission for proposed biosimilar adalimumab accepted by FDA novartis.com ↗

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 6 sources stand behind the page.

FieldValueCited text
Known as FKB327 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02405780 ↗
1

NCT02260791 ↗
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
Known as Adalimumab biosimilar “switched to adalimumab biosimilar (Hyrimoz®) 40 mg s.c. every 2 weeks until Week 34.” NCT03906136 ↗
Known as HLX03 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03357939 ↗
1

NCT03316781 ↗
Known as Hyrimoz “switched to adalimumab biosimilar (Hyrimoz®) 40 mg s.c. every 2 weeks until Week 34.” NCT03906136 ↗
Action Inhibit “Anti-TNFα” NCT03316781 ↗
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 ↗
Target TNF “Anti-TNFα Human Monoclonal Antibody” NCT03316781 ↗