First European ustekinumab biosimilar to Stelara approved

The European Commission (EC) has granted a marketing authorisation for Uzpruvo^® (AVT04) in Europe, a biosimilar candidate to Stelara^® (ustekinumab).

Ustekinumab biologic

Ustekinumab is a human IgG1κ monoclonal antibody (mAb). Uzpruvo is produced in Sp2/0 cells via perfusion, in the same way that the reference product Stelara is. The biologic targets the p40 protein, which has key roles in treating immune-mediated diseases like Crohn’s disease, psoriasis as well as psoriatic arthritis, Alvotech highlighted.

Once the European Supplementary Protection Certificate (SPC) for Stelara expires in July 2024, this will open up market entry as soon as possible for Uzpruvo, now that it is approved in Europe.

The EU ustekinumab market is worth €2.5 billion, so biosimilar competition could significantly expand patient access to this biologic therapy within the fields of gastroenterology, dermatology, and rheumatology, according to STADA and Alvotech.

A new European biosimilar approval

“This first marketing authorisation for biosimilar ustekinumab in Europe offers the potential to expand substantially patient access through competition. By adding to our current roster of six marketed biosimilars, STADA looks forward to offering Europe’s gastroenterologists, dermatologists, and rheumatologists a further cost-effective treatment option,” noted STADA’s Global Specialty Head, Bryan Kim.

“We look forward to spearheading biosimilars competition in the ustekinumab market and increasing patient access to biologic therapies for inflammatory conditions as we have done with our adalimumab biosimilar, launched last year,” shared Anil Okay, Chief Commercial Officer of Alvotech.

This marketing authorisation follows the Committee for Medicinal Products for Human Use (CHMP) positive opinion for Uzpruvo in November 2023, recommending it for Crohn’s disease, psoriasis and psoriatic arthritis.

Alvotech is mainly responsible for developing and manufacturing the AVT04 ustekinumab biosimilar, while STADA has commercial rights within Europe. In this region, STADA already has six biosimilars approved in this market.

Clinical efficacy of AVT04

In February 2023, data for AVT04 from the AVT04-GL-301 confirmatory clinical, safety and efficacy study showed that AVT04 and Stelara had therapeutic equivalence in moderate to severe chronic plaque-type psoriasis.