Samsung Bioepis-NIPRO alliance boosts biosimilar pipeline in Japan’s $1.4B market

Samsung Bioepis Co., Ltd. (KRX: 207940), the biopharmaceutical arm of Samsung Group, has announced a comprehensive license, development, and commercialization agreement with Japan‘s NIPRO Corporation. This strategic alliance marks a significant move in expanding the South Korean biosimilar leader’s footprint in Japan’s high-value healthcare ecosystem. The companies aim to jointly introduce multiple biosimilar candidates in the Japanese market, targeting immunology and potentially other chronic disease segments.

This development is the latest in a wave of global pharmaceutical consolidation efforts, aimed at optimizing regional access to biosimilars—a segment growing at a CAGR of over 20% globally as healthcare systems battle rising biologic costs and aging populations.

The announcement signals Samsung Bioepis’s intensified focus on Asia-Pacific expansion amid a maturing European biosimilars market and slowing U.S. approvals. For NIPRO Corporation, the partnership broadens its pharmaceutical portfolio beyond medical devices and diagnostics into high-growth biologics—positioning it as a key player in Japan’s biosimilar acceleration strategy.

What Is the Scope of the Samsung Bioepis–NIPRO Biosimilar Agreement?

Under the agreement, Samsung Bioepis will retain responsibility for development, manufacturing, and regulatory submission of biosimilar candidates including SB17—its ustekinumab biosimilar referencing Janssen’s Stelara, a key treatment for autoimmune disorders. NIPRO will spearhead local marketing, distribution, and physician engagement activities across Japan.

The partnership draws on Samsung Bioepis’s global expertise in biosimilar R&D and production—backed by the company’s proven portfolio that includes biosimilars for adalimumab, etanercept, infliximab, trastuzumab, and bevacizumab—and pairs it with NIPRO’s strong local sales force, regulatory familiarity, and hospital networks in Japan.

SB17 is especially strategic, as Stelara generated $10.9 billion in global sales in 2023. Its biosimilar version is expected to be among the next big opportunities post-patent expirations, with Japan’s Ministry of Health, Labour and Welfare (MHLW) already indicating a willingness to approve biosimilars with streamlined bridging studies.

How Does This Reflect Broader Trends in the Biosimilars Sector?

The partnership between Samsung Bioepis and NIPRO aligns with the evolving global biosimilar landscape, where Big Pharma is increasingly dependent on regional players for market penetration. As biologic patents expire, biosimilar uptake is becoming essential for reducing treatment costs and maintaining health system sustainability.

Japan has historically been slower to adopt biosimilars compared to the U.S. or EU due to conservative regulatory practices and physician caution. However, policy shifts since 2021—including national reimbursement support, educational programs, and updated approval guidelines—are accelerating adoption.

According to IQVIA, Japan’s biosimilar market was valued at ¥200 billion (~$1.4 billion) in 2024 and is expected to exceed ¥500 billion by 2029. Samsung Bioepis and NIPRO’s alliance places them at the center of this anticipated surge.

Globally, biosimilars saved healthcare systems over $24 billion in 2023 alone, with leading companies like Amgen (NASDAQ: AMGN), Pfizer (NYSE: PFE), and Samsung Bioepis aggressively expanding biosimilar pipelines to gain first-mover advantages.

What Is the Financial Position of Samsung Bioepis in the Global Biologics Market?

Samsung Bioepis reported over ₩900 billion (~$675 million) in revenue in 2024, marking a year-over-year growth of 19%. The company’s EBITDA margin stood at 29%, driven by operational efficiency in its Incheon-based biologics production hub and increasing contribution from high-margin oncology biosimilars.

Its parent, Samsung Biologics (KRX: 207940), remains one of the world’s largest contract development and manufacturing organizations (CDMOs), with over 600KL of bioreactor capacity as of Q1 2025. The synergy between the two arms provides Samsung Bioepis with access to large-scale GMP-compliant manufacturing, enabling rapid scale-up and cost competitiveness.

In terms of biosimilar market share, Samsung Bioepis ranks among the top five globally by volume, alongside Sandoz, Celltrion (KRX: 068270), Amgen, and Viatris (NASDAQ: VTRS). Analysts project Samsung Bioepis’s revenue to cross ₩1.1 trillion in 2025, driven largely by Japanese and U.S. expansions.

What Are Early Market Reactions to the Samsung Bioepis-NIPRO Deal?

Although neither Samsung Bioepis nor NIPRO Corporation is listed on U.S. exchanges, the announcement has sparked attention in Asian investor circles. Samsung Biologics’ stock (KRX: 207940) rose 1.8% on the day of the announcement, reflecting modest investor optimism about expanded monetization channels in Japan.

Market sentiment is cautiously optimistic, with analysts highlighting Japan’s pricing controls and prescriber conservatism as long-term adoption risks. However, NIPRO’s extensive reach across Japan’s hospitals and clinics is expected to mitigate these challenges through on-the-ground detailing and physician education.

Institutional flows into Samsung Biologics have remained steady, with foreign institutional investors (FIIs) holding approximately 11% of the company’s float as of May 2025. Domestic investors continue to show strong confidence, bolstered by consistent earnings growth and aggressive R&D spending (12.4% of FY24 revenue).

How Will This Affect Japan’s Healthcare Access and Biologic Drug Costs?

Japan’s National Health Insurance system (NHI) has long sought to curtail escalating biologic drug spending. According to MHLW data, biologics accounted for over 35% of prescription drug costs in Japan in 2023 despite comprising less than 5% of total prescriptions.

Biosimilars like SB17 could offer discounts of 30–50% compared to originator drugs. The potential cumulative savings to NHI over the next decade could reach billions of yen, especially if similar biosimilars targeting oncology (e.g., bevacizumab), endocrinology (e.g., insulin glargine), and autoimmune diseases are launched.

By partnering with a trusted domestic player, Samsung Bioepis enhances the likelihood of successful uptake—enabling Japanese patients broader access to life-saving therapies with reduced economic burden. Additionally, by increasing domestic availability, the collaboration reduces Japan’s reliance on imported biologics, aligning with national healthcare resilience objectives.

What Does This Deal Mean for NIPRO Corporation’s Growth Strategy?

NIPRO Corporation has long been a dominant player in dialysis equipment, glass products, and intravenous solutions in Japan and overseas. But the company has recently signaled ambitions to deepen its footprint in the pharmaceutical and biologics domain.

The Samsung Bioepis partnership provides NIPRO with high-quality biosimilar assets without the capital-intensive requirement of in-house biologics development. With over ¥440 billion (~$3 billion) in annual revenue and R&D intensity under 5%, NIPRO gains new revenue streams that complement its existing hospital-facing businesses.

This move also aligns with Japan’s “Pharmaceutical Strategy Vision 2030,” which emphasizes enhanced public-private collaboration to promote biosimilar usage, manufacturing localization, and accelerated market entry of innovative treatments.

What Can Investors Expect from Samsung Bioepis and the Broader Biosimilars Sector?

The Samsung Bioepis-NIPRO collaboration is expected to accelerate commercialization timelines for biosimilars in Japan, with regulatory filings for SB17 likely by late 2025 or early 2026, subject to MHLW review processes.

Analysts expect further M&A and partnership activity in the biosimilars space, particularly as Japanese pharma companies seek access to large-scale biologics manufacturing and global firms look to deepen APAC penetration.

Samsung Bioepis has signaled intentions to launch at least five new biosimilars globally by 2028, with a focus on autoimmune diseases, ophthalmology, and oncology. It is also exploring subcutaneous formulation innovations and digital adherence tools to increase product differentiation.

The outlook for the biosimilars industry remains robust. As more blockbuster biologics lose exclusivity—including Keytruda (pembrolizumab) and Eylea (aflibercept)—biosimilar developers with scalable production, robust clinical data, and strong commercial partners will be best positioned to capture value. Samsung Bioepis’s alliance with NIPRO Corporation is more than a simple licensing arrangement—it is a convergence of industrial expertise, healthcare policy alignment, and strategic market entry. With Japanese regulators and payers warming up to biosimilars, the partnership could become a catalyst for systemic transformation in Japan’s biologic drug landscape. As the global biosimilar race intensifies, Samsung Bioepis continues to prove it is not merely participating—but shaping the future of affordable biologic access across geographies