STADA and Alvotech’s win first EU-approval for Stelara biosimilar

STADA and Alvotech received a marketing authorisation from the European Commission for Uzpruvo (AVT04), which will make it the first approved biosimilar to Johnson and Johnson’s drug Stelara (ustekinumab) in the European Economic Area (EEA).

This authorisation in the EEA opens the door for more competition to enter the ustekinumab market within the region.

In November 2023, the Committee for Medicinal Products for Human Use (CHMP) gave the biosimilar a positive opinion. This was based on data from the AVT04-GL-301 confirmatory clinical trial, which showed that Uzpruvo reached therapeutic equivalence with Stelara in patients with moderate to severe chronic plaque-type psoriasis. The committee also considered positive pharmacokinetic similarity data from the AVT04-GL-101 in its decision.

The European Commission has approved Johnson and Johnson’s Stelara as a treatment for plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. The US-headquartered company will reach the expiry date for its Supplementary Protection Certificate (SPC) for Stelara on 19 July 2024. SPC protect intellectual property as an extension of patent rights.

Ustekinumab is a monoclonal antibody therapy that attaches to interleukin 12 and interleukin 23. This blocks their activity, reducing immune activity and disease symptoms.

Alvotech and STADA first joined their biosimilar strategic partnership in 2019. Under the agreement, Alvotech became responsible for the production, registration, and supply of biosimilars in the EU, whilst STADA took charge of commercialising the therapies in most European markets. At the time, the initial seven biosimilar pipeline was already generating $50 bn in sales globally, as per a November 2019 press release.

In the US, Uzpruvo was initially rejected due to manufacturing issues. In October 2023, the US Food and Drug Administration (FDA) issued a complete response letter, noting deficiencies in its inspection of Alvotech’s Reykjavik facility that concluded in March 2023. In October 2023, the agency said that the Iceland-headquartererd company would have to correct these issues before submitting a new Biologics Licensing application.

In a 10 January press release, Bryan Kim, STADA’s Global Specialty Head, said, “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.”

Sign up for our daily news round-up!

Give your business an edge with our leading industry insights.