Alvotech receives Japanese approval for three new biosimilars

REYKJAVIK - Alvotech (NASDAQ:ALVO), a profitable biosimilar company with a market capitalization of $2.45 billion and impressive revenue growth of 82% over the last twelve months, announced Friday that its Japanese partner Fuji Pharma has secured marketing approval for three biosimilar medicines from Japan’s Ministry of Health, Labor and Welfare. According to InvestingPro analysis, the company is currently trading near its 52-week low, suggesting potential value opportunity for investors interested in the biosimilars sector.

The approved products include AVT03 (biosimilar to denosumab), AVT05 (biosimilar to golimumab), and AVT06 (biosimilar to aflibercept). According to the company, AVT05 represents the first golimumab biosimilar approved for sale in major markets globally. With a strong gross profit margin of 53.88% and positive net income, Alvotech demonstrates solid financial fundamentals. For detailed analysis and additional insights, investors can access the comprehensive Pro Research Report available on InvestingPro.

AVT03 has been approved for treating bone lesions due to multiple myeloma or metastases of solid tumors. AVT05 received approval for rheumatoid arthritis in patients who haven’t responded adequately to conventional treatments. AVT06 was approved for age-related macular degeneration, macular edema, and choroidal neovascularization.

"We are thrilled to receive marketing approvals for three additional biosimilars in Japan, after our successful launch last year with Fuji Pharma of our biosimilar to Stelara," said Robert Wessman, chairman and CEO of Alvotech, in the press release statement.

This development follows the May 2024 launch of the first biosimilar to Stelara (ustekinumab) in Japan through the Alvotech-Fuji Pharma partnership, which was established in November 2018.

Beyond the four approved biosimilars, Alvotech has licensed commercial rights in Japan to Fuji Pharma for two additional biosimilar candidates currently under development.

Alvotech focuses exclusively on developing and manufacturing biosimilar medicines. The company has established multiple commercial partnerships globally to distribute its products across various markets including the United States, Europe, Japan, China, and regions of South America, Africa, and the Middle East.

In other recent news, Alvotech reported impressive financial results for the second quarter of 2025. The company achieved an earnings per share of $0.50, significantly exceeding the forecasted -$0.0023, which represents a remarkable earnings surprise of 21,839.13%. Revenue also outperformed expectations, reaching $204.7 million compared to the anticipated $120.51 million, resulting in a 69.86% revenue surprise. Despite these strong financial results, the market’s immediate reaction was negative. Alvotech’s stock price experienced a decline of 2.02% in after-hours trading. These developments highlight the company’s robust performance in the biosimilar industry. Investors may find these figures noteworthy as they reflect Alvotech’s capacity to surpass market projections.

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