Stada, Alvotech get first EU approval for biosimilar Stelara

Johnson & Johnson’s blockbuster immunology drug Stelara is facing its first approved biosimilar in Europe, which is due to launch after the drug loses EU patent protection in July.

The European Commission has approved a biosimilar of the IL-12 and IL-23 inhibitor antibody developed by STADA and partner Alvotech – called Uzpurvo – for the treatment of plaque psoriasis, psoriatic arthritis, and Crohn’s disease.

Stelara (ustekinumab) was launched almost 15 years ago as a treatment for psoriasis and in the interim has picked up additional indications in psoriatic arthritis, Crohn’s disease, and ulcerative colitis, building its annual worldwide sales to almost $10 billion in 2022 – around 10% of J&J’s total revenues.

STADA and Alvotech estimate that the European market for the drug is worth around €2.5 billion (around $2.7 billion), and say that the availability of Uzpurvo (formerly AVT04) will expand access to ustekinumab for the three approved indications.

J&J’s brand was approved in the EU for ulcerative colitis in 2019 and still has patent protection for that use.

The approval of Uzpurvo was awarded on the back of the AVT04-GL-301 clinical trial, which showed therapeutic equivalence on efficacy and safety between AVT04 and Stelara in patients with moderate to severe chronic plaque-type psoriasis, as well as pharmacokinetic similarity. The drug was developed by Alvotech, while Stada has commercial rights within Europe.

“Biosimilar competition upon expiry of EU exclusivity rights for Stelara offers a significant opportunity to improve patient access at the same, or even lower, costs to European healthcare systems,” said STADA in a statement.

The German company – which confirmed last year it had been in exploratory talks over a possible sale – already markets six approved biosimilars in Europe, including an Alvotech-partnered version of AbbVie’s immunology blockbuster Humira (adalimumab).

J&J, meanwhile, is also facing the threat of earlier-than-expected biosimilar competition to Stelara in the US, after health plan CareFirst BlueCross BlueShield filed a lawsuit accusing the company of unlawfully extending patent protection for the drug.

The complaint accuses the pharma company of acquiring a method-of-use patent “by fraud” to extend patent protection for Stelara beyond the US expiry date of 25th September last year to 1st January 2025.

If the lawsuit is successful, it could allow lower-priced biosimilars of Stelara to launch during 2024, potentially saving around a billion dollars in overpayments for US health systems, according to court documents.

The first Stelara biosimilar to be approved in the US was Amgen’s Wezlana, which was given interchangeable status by the FDA last October.