Drugs / AVT04
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed arthritic joint disease 2 milestones | |||||
| Filed | EU (EMA) | — | arthritic joint disease | 2023-02-09 | “In February 2023 Alvotech announced that a Marketing Authorization Application (MAA) filing for the biosimilar candidate was accepted by the European Medicines Agency’s (EMA)” alvotech.com ↗ “In February 2023, the partners announced that that the EMA had accepted their marketing authorization application for AVT04” alvotech.com ↗ “the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT04” alvotech.com ↗ |
| Filed | US (FDA) | — | arthritic joint disease | 2023-01-06 | “in January 2023 that a Biologics License Application (BLA) was accepted for review by the U.S. Food and Drug Administration’s (FDA).” alvotech.com ↗ “the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT04” tevapharm.com ↗ |
| Filed Indication not stated 3 milestones | |||||
| Filed | US (FDA) | — | — | 2023-11-28 | “Alvotech resubmitted BLA for AVT04, has also been accepted by the FDA, with a BsUFA goal date of April 16, 2024.” alvotech.com ↗ |
| Rejected (CRL) | US (FDA) | — | — | 2023-10-12 | “announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT04” alvotech.com ↗ |
| Filed | Japan (PMDA) | — | — | 2022-11-16 | “submitted an application to the Japanese Ministry of Health, Labor and Welfare for marketing approval of AVT04, biosimilar to Stelara® (ustekinumab)” alvotech.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT04744363 | May 2021 → Mar 2022 | psoriasis | Alvotech Swiss AG | Completed | Met primary |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT04930042 | Jun → Dec 2021 | psoriasis | Alvotech Swiss AG | Completed | Met primary |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2024-04-16 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Alvotech and Teva Announce U.S. FDA Approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara® (ustekinumab) tevapharm.com ↗
The FDA approval of SELARSDI, referred to as AVT04 during development, was based on a totality of evidence, including analytical and clinical data. |
| 2024-01-19 | Alvotech Swiss AG | Regulatory Alvotech Provides Update on Status of Biologics License Applications for AVT02 and AVT04 alvotech.com ↗
Following the FDA inspection, Alvotech received a form 483 with one observation. |
| 2024-01-10 | Alvotech Swiss AG | Regulatory STADA and Alvotech Secure Approval for Uzpruvo, Europe’s First Ustekinumab Biosimilar to Stelara alvotech.com ↗
Partners STADA and Alvotech today announced that the European Commission issued a marketing authorization for Uzpruvo® (AVT04), a biosimilar candidate to Stelara® (ustekinumab). |
| 2023-11-14 | Alvotech Swiss AG | Regulatory Alvotech and JAMP Pharma Announce Receipt of Marketing Authorization for Jamteki (AVT04), the First Biosimilar of Stelara® (ustekinumab) alvotech.com ↗
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and JAMP Pharma Group (“JAMP Pharma”), a Canadian owned pharmaceutical organization headquartered in the Greater Montreal area, announced today that Health Canada has granted JAMP Pharma marketing authorization for AVT04, a biosimilar to Stelara® (ustekinumab) developed by Alvotech. |
| 2023-11-10 | Alvotech Swiss AG | Regulatory STADA and Alvotech receive positive CHMP opinion for Europe’s first ustekinumab biosimilar to Stelara alvotech.com ↗
Partners STADA and Alvotech today announced that the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency’s (EMA) has adopted a positive opinion for Uzpruvo (AVT04), a biosimilar candidate to Stelara® (ustekinumab). |
| 2023-10-12 | Alvotech Swiss AG | Regulatory Alvotech Provides Update on Status of U.S. Biologics License Application for AVT04 alvotech.com ↗
As expected, the CRL noted that certain deficiencies, which were conveyed following the FDA’s inspection of the company’s Reykjavik facility that concluded in March 2023, must be satisfactorily resolved before the application can be approved. |
| 2023-09-25 | Alvotech Swiss AG | Regulatory Alvotech Announces Approval in Japan of AVT04 (ustekinumab), a Biosimilar to Stelara® alvotech.com ↗
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that its commercialization partner in Japan, Fuji Pharma Co., Ltd. (“Fuji”), has received marketing approval for AVT04 (ustekinumab), a biosimilar to Stelara®, from the Japanese Ministry of Health, Labor and Welfare. |
| 2023-02-09 | Alvotech Swiss AG | Regulatory EMA Confirms Acceptance of Application for AVT04, a Proposed Biosimilar to Stelara® (ustekinumab) alvotech.com ↗
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and global pharmaceutical company STADA Arzneimittel (STADA) today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT04, Alvotech’s proposed biosimilar to Stelara® (ustekinumab). |
| 2023-01-06 | Alvotech Swiss AG | Regulatory Alvotech and Teva Announce Acceptance of U.S. Biologics License Application for AVT04, a Proposed Biosimilar to Stelara® (ustekinumab) alvotech.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT04, Alvotech’s proposed biosimilar to Stelara® (ustekinumab), which is prescribed to treat a variety of inflammatory conditions. |
| 2023-01-06 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Alvotech and Teva Announce Acceptance of U.S. Biologics License Application for AVT04, a Proposed Biosimilar to Stelara® (ustekinumab) tevapharm.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT04, Alvotech’s proposed biosimilar to Stelara® (ustekinumab), which is prescribed to treat a variety of inflammatory conditions. |
| 2022-05-24 | Alvotech Swiss AG | Results Alvotech Clinical Study Results Demonstrate Therapeutic Equivalence between Biosimilar Candidate AVT04 and Reference Product Stelara® alvotech.com ↗
The confirmatory clinical, safety and efficacy study for AVT04, biosimilar candidate to Stelara® (ustekinumab) met its primary endpoint. |
| 2022-05-16 | Alvotech Swiss AG | Results Alvotech Announces Positive Results from a Pharmacokinetic Similarity Study for AVT04, a Proposed Biosimilar to Stelara® alvotech.com ↗
The study results demonstrated bioequivalence between AVT04 and the reference products. |
All press releases naming this drug 17 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AVT04 | “A randomized, double-blind, 3-arm, parallel study assessing the pharmacokinetics, safety, tolerability and immunogenicity of AVT04, an ustekinumab candidate biosimilar, in...” PMID 37212315 ↗ May 2023 |
| Modality | Monoclonal antibody | “AVT04 is a fully human immunoglobulin class G1κ monoclonal antibody” NCT04930042 ↗ |
| Route | Subcutaneous | “when administered as a single 45 mg/0.5 mL SC injection” NCT04744363 ↗ |