Alvotech's Expansion in the Japanese Biosimilars Market and Its Strategic Implications for Long-Term Growth

Japan's biosimilars market is emerging as a critical battleground for global biopharma players, driven by a rapidly aging population, rising healthcare costs, and aggressive government initiatives to promote cost-effective treatments. Alvotech, a leader in biosimilar development, has positioned itself at the forefront of this expansion through a strategic partnership with Fuji Pharma Co., Ltd. In September 2025, Fuji Pharma secured marketing approval for three Alvotech-developed biosimilars—AVT03 (denosumab), AVT05 (golimumab), and AVT06 (aflibercept)—from the Japanese Ministry of Health, Labor and WelfareJapan Biosimilars Market Share, Growth and Forecast 2032^[1]. AVT05, in particular, marks a milestone as the first golimumab biosimilar approved in major global marketsAlvotech receives Japanese approval for three new biosimilars^[2], underscoring Alvotech's ability to pioneer in competitive therapeutic categories.

A High-Growth Market with Strategic Opportunities

The Japanese biosimilars market is projected to grow at a compound annual growth rate (CAGR) of 22.7% between 2025 and 2033, reaching USD 3.4 billion by 2033Japan Biosimilar Market Size, Share and Forecast to 2033^[4]. This expansion is fueled by the increasing prevalence of chronic diseases such as rheumatoid arthritis and age-related macular degeneration, alongside regulatory reforms that streamline biosimilar approvals. For context, the market size reached USD 475.8 million in 2024Alvotech and Fuji Pharma Announce Marketing Approval for Three New Biosimilars in Japan^[3], and by FY2033, it could surpass USD 1.1 billion at a 9.33% CAGRJapan Biosimilars Market Share, Growth and Forecast 2032^[1]. Alvotech's entry into this market aligns with a broader industry shift toward value-driven therapies, where biosimilars offer a 30–50% cost reduction compared to originator biologicsJapan Biosimilar Market Size, Share and Forecast to 2033^[4].

Competitive Positioning: Innovation and Local Expertise

Alvotech's partnership with Fuji Pharma exemplifies a hybrid model that combines global R&D capabilities with localized commercialization expertise. By outsourcing manufacturing and development, Alvotech leverages Fuji Pharma's deep understanding of Japan's regulatory and reimbursement landscape, while Fuji Pharma gains access to a robust pipeline of biosimilars. This collaboration has already yielded results: the duo launched a biosimilar to ustekinumab (Stelara®) in May 2024Japan Biosimilars Market Share, Growth and Forecast 2032^[1], and now six biosimilars are in various stages of development or approvalAlvotech and Fuji Pharma Announce Marketing Approval for Three New Biosimilars in Japan^[3].

The competitive landscape in Japan remains fragmented, with Celltrion's Herzuma biosimilar dominating with a 74% market share as of November 2024Japan Biosimilars Market Share, Growth and Forecast 2032^[1]. However, Alvotech's focus on high-value, complex molecules—such as AVT05's golimumab, used in rheumatoid arthritis and Crohn's disease—positions it to capture market share in niche but high-growth segments. AVT05's global first-in-class approval provides a significant first-mover advantage, enabling Alvotech to establish brand recognition and physician trust ahead of potential competitorsAlvotech receives Japanese approval for three new biosimilars^[2].

Financial Performance and Long-Term Implications

Alvotech's financials reflect the success of its biosimilar strategy. In the first half of 2025, the company reported a net profit of USD 141.7 million, driven by strong sales of its biosimilar portfolioJapan Biosimilar Market Size, Share and Forecast to 2033^[4]. While Japan's contribution to this figure is unspecified, the country's growing market and Alvotech's expanding product pipeline suggest a scalable revenue opportunity. The company's partnership model also reduces capital intensity, allowing it to allocate resources to high-potential markets like Japan without overextending operational capacityAlvotech and Fuji Pharma Announce Marketing Approval for Three New Biosimilars in Japan^[3].

Strategic Risks and Mitigation

Despite its strengths, Alvotech faces challenges. The Japanese market is highly competitive, with established players like Celltrion and Samsung Bioepis dominating key segments. Additionally, biosimilars require rigorous clinical validation, and post-marketing studies could delay adoption. However, Alvotech's focus on differentiated molecules and its partnership with Fuji Pharma—whose local sales force and regulatory expertise are critical—mitigate these risks. The company's pipeline also includes two additional biosimilars under development in JapanJapan Biosimilars Market Share, Growth and Forecast 2032^[1], ensuring a steady stream of revenue drivers.

Conclusion: A Value-Driven Play in a Transforming Market

Alvotech's expansion in Japan reflects a calculated, value-driven approach to biosimilar commercialization. By combining innovative product development with strategic local partnerships, the company is well-positioned to capitalize on Japan's high-growth biosimilars market. As global healthcare systems prioritize cost containment, Alvotech's ability to deliver high-quality, affordable biologics will likely translate into sustained revenue growth and long-term shareholder value. Investors should monitor the company's progress in Japan, where its recent approvals and pipeline depth could redefine its competitive positioning in the Asia-Pacific region.