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Alvotech to Launch Biosimilar of Johnson & Johnson's Psoriasis Drug in Japan, Canada, and Europe

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Mason Walker
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Alvotech to Launch Biosimilar of Johnson & Johnson's Psoriasis Drug in Japan, Canada, and Europe

Alvotech to Launch Biosimilar of Johnson & Johnson's Psoriasis Drug in Japan, Canada, and Europe

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Biotech company Alvotech has announced that it has reached settlement agreements with Johnson & Johnson to launch a biosimilar of the pharmaceutical giant's psoriasis drug, Stelara, in Japan, Canada, and the European Economic Area (EEA). The biosimilar, known as AVT04, is a monoclonal antibody and has already received regulatory approval in these regions. Market applications are pending in additional global markets, including the U.S. This development marks a significant event in the pharmaceutical industry's biosimilar market.

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Tentative Market Entry Dates for AVT04

Alvotech has provided some tentative dates for the market entry of AVT04 in these regions. In Canada, the biosimilar is expected to enter the market in the first quarter of 2024. For Japan, market entry is anticipated after the upcoming round of National Health Insurance reimbursement price listings in May 2024. Meanwhile, the first European markets are set to see the biosimilar as soon as possible after the expiration date of the European Supplementary Protection Certificate for Stelara in late July 2024.

Global Reach and Local Expertise

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With a network of strategic commercial partnerships, Alvotech plans to launch the biosimilar in these global markets, thereby increasing patient access to this vital biologic. The biosimilar will be marketed under various names, including Ustekinumab BS F in Japan, Jamteki in Canada, and Uzpruvo in some countries in the EEA. Notably, Alvotech's stock has risen 17.6% in the last 12 months, signaling the market's positive response to these developments.

Legal Issues Surrounding Johnson & Johnson

In other news, Johnson & Johnson is facing legal issues, with a patient filing a class-action complaint against the company for allegedly violating the Employee Retirement Income Security Act (ERISA). The complaint alleges mismanagement of prescription drug benefits, leading to inflated costs for generic drugs.

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The Impact of Biosimilars

The use of biosimilars is generating significant savings for various healthcare systems. For instance, they have led to substantial savings for Medicare Part B programs and beneficiaries. Similarly, within Poland’s public payer system, the use of biosimilars has resulted in savings of €243 million. This underlines the importance of biosimilars in enhancing the affordability of healthcare globally.

Alvotech's Commitment to Biosimilars

As a biotech company, Alvotech is committed to the development and manufacture of biosimilar medicines for patients worldwide. The company has also reached a settlement and license agreement with Teva for the entry of AVT04 in the U.S. by February 21, 2025, pending FDA approval. This commitment underscores Alvotech’s dedication to increasing patient access to vital biologics and driving down healthcare costs through the production of biosimilars.

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