Ustekinumab Biosimilar - Alvotech and Teva Settlement

Alvotech, a renowned global biotech company specializing in biosimilar medicines, has joined forces with Teva Pharmaceuticals to secure a significant milestone for AVT04, their proposed biosimilar to Stelara® (Ustekinumab). This groundbreaking agreement, announced on June 12, 2023, includes a settlement and license agreement with Johnson & Johnson. The collaboration paves the way for AVT04's entry into the United States, with a license date expected no later than February 21, 2025.

Also Read This: On May 22, 2023, Janssen and Amgen filed a Stipulation and Order of Dismissal

About AVT04 (Ustekinumab):

AVT04, an investigational product developed by Alvotech, represents a promising biosimilar candidate to Stelara® (Ustekinumab). As a monoclonal antibody, AVT04 specifically targets and binds to two cytokines, namely IL-12 and IL-23. These cytokines play crucial roles in both inflammatory and immune responses within the body.

Regulatory Status of AVT04:

It is important to note that AVT04 has not received regulatory approval in any country at present. As such, biosimilarity to Stelara® (Ustekinumab) has not been established by regulatory authorities, nor is it currently claimed.

The recent collaboration between Alvotech, Teva Pharmaceuticals, and Johnson & Johnson marks an important milestone in the journey towards introducing AVT04, a proposed biosimilar to Stelara®, into the United States market. While AVT04 is still undergoing regulatory evaluation, its potential to address inflammatory and immune responses provides hope for patients seeking innovative treatment options. Stay tuned for further updates on AVT04 as it progresses towards regulatory approval and potential market availability.

Source: Alvotechand Teva Secure U.S. License Date for AVT04, a Proposed Biosimilar to Stelara®

Status of other Biosimilars’ for Ustekinumab:

Amgen:

On May 22, 2023 Janssen and Amgen filed a Stipulation and Order of Dismissal with Prejudice indicating that the parties have agreed to settle the litigation and dismiss the action with prejudice.

According Reuters, “Amgen said in a statement on Tuesday that the settlement terms are confidential, but it will allow the company to sell its biosimilar of Stelara "no later than January 1st, 2025."

Alvotech and STADA Arzneimittel:

The USFDA: In January 2023, the FDA accepted a biologics license application.

The European Union (EU): Currently reviewing an application for an Ustekinumab biosimilar.

Fresenius Kabi:

Partnered with Formycon to develop an Ustekinumab Biosimilar (Click Here to view Press Release)

Samsung Bioepis: 

Samsung Bioepis Presented Phase 1 Study Results of SB17 (Ustekinumab), A Proposed Biosimilar to Stelara, at 2023 AAD Annual Meeting (Click Here to view Press Release) 

Dong-A ST:

In January 2023, announced that results of a phase 3 therapeutic equivalence study demonstrated that its Ustekinumab biosimilar (DMB-3115) has similar safety and efficacy profiles to Stelara (Source: Dong-AST Demonstrates Therapeutic Equivalence Between DMB-3115 and Stelara in GlobalPhase III)