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Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar

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The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.

The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products; and Evernorth announced that it is set to cover an adalimumab biosimilar for $0 out of pocket (OOP) for eligible patients.

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EU Ustekinumab Approval

The European Commission granted marketing authorization to Pyzchiva, an ustekinumab biosimilar referencing Stelara. The biosimilar was approved for the treatment of several autoimmune disorders, including psoriatic arthritis, plaque psoriasis, Crohn disease, and ulcerative colitis.

“We are proud to have our fourth immunology biosimilar approved in Europe,” said Byoungin Jung, vice president and regulatory affairs team leader at Samsung Bioepis. “With the latest approval, we are pleased to make an important progress towards providing additional treatment options for patients suffering chronic, autoimmune diseases in Europe.”

The approval was based on a data package comparing Pyzchiva with Stelara across multiple studies. Phase 1 trials in healthy volunteers and phase 3 trials in patients with plaque psoriasis showed comparable efficacy, safety, and pharmacokinetics between Pyzchiva and Stelara. Sandoz, in partnership with Samsung Bioepis, will commercialize Pyzchiva in the US, Canada, the European Economic Area, Switzerland, and the United Kingdom following their agreement in September 2023.

New Golimumab Biosimilar Data

Alvotech shared positive results from a comformatory clinical study evaluating the safety and efficacy of AVT05, a golimumab biosimilar, compared with its reference products (Simponi and Simponi Aria).

The trial was a randomized, double-blind, 2-arm, multicenter analysis looking at the effects of AVT05 vs Simponi in patients with moderate to severe rheumatoid arthritis. The primary outcome measure was change in disease activity score measurements from baseline to week 16. Alvotech said the study met its primary end point and no clinically meaningful differences in safety were observed through week 24.

“We are delighted at passing yet another clinical milestone in our pipeline,” said Robert Wessman, chairman and CEO of Alvotech. “We intend to file marketing applications for AVT05 in major global markets this year, which adds to the continued diversification of our portfolio and further demonstrates the capabilities of our biosimilar-dedicated platform.”

If approved by regulatory agencies, AVT05 will be marketed by Teva Pharmaceuticals in the US, Advanz Pharma in Europe, and Fuji Pharma in Japan.

Evernorth to Cover Adalimumab Biosimilar Without OOP Costs

Evernorth Health Services announced that it will offer a biosimilar to Humira (adalimumab) for $0 OOP costs for eligible patients enrolled in its specialty pharmacy Accredo. The policy will go into effect in June.

The product chosen is Boehringer Ingelheim's Cyltezo, which of the 10 FDA-approved adalimumab biosimilars. Cyltezo is offered with both low- and high-concentration options and is 1 of 3 adalimumab biosimilars with an interchangeability designation. Through agreements with multiple manufacturers, the biosimilar will be produced for Evernorth’s affiliate private label pharmaceutical distributor, Quallent Pharmaceuticals.

Most patients enrolled in Quallent’s co-payment assistance program will be able to obtain the product at $0 OOP, and the program is anticipated to save individual patients an average of $3500 per year.

"Biosimilars can help drive significant savings for patients and their health plans now and into the future. To help achieve those savings, it is important to make sure patients are supported and their experience is seamless," said Matt Perlberg, president of Evernorth Health Services' pharmacy and care delivery businesses.

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