Samsung Bioepis Explores Organon Acquisition to Shift from Partner-Based to Direct Sales Model
核心洞察
Samsung Bioepis (搜索) is exploring the acquisition of its U.S. sales partner Organon as part of a strategic shift from indirect to direct sales to capture higher profit margins and strengthen market control.
The company has already begun transitioning to direct sales in Europe, reclaiming commercialization rights for Byooviz from Biogen and now directly selling four products in the European market.
This strategic pivot comes as Samsung Bioepis (搜索) faces intensifying biosimilar competition and seeks to maximize cash generation to fund its new drug development pipeline, including ADC candidates developed with partners like IntoCell (搜索).
Samsung Bioepis (搜索) is exploring the acquisition of its U.S. sales partner Organon as part of a comprehensive strategy to transition from partner-based distribution to direct sales, according to industry sources. The company completed the first round of due diligence at the end of last year, with next steps currently underway, though the transaction remains uncertain.
The strategic shift represents a fundamental change for Samsung Bioepis (搜索), which has maintained an indirect sales system since 2015, distributing biosimilar products through multiple partners in global markets including the United States and Europe. The company is also reviewing acquisitions of other corporations beyond Organon as it seeks to strengthen its global commercialization capabilities.
Direct Sales Strategy Gains Momentum
Samsung Bioepis (搜索) has already begun implementing its direct sales approach in Europe. The company recently reclaimed European commercialization rights for the ophthalmic disease (搜索) treatment Byooviz from its U.S. marketing partner Biogen and now sells a total of four products directly in the European market.
The transition to direct sales offers significant financial advantages. According to industry analysis, domestic pharmaceutical and bio corporations typically pay partners fees equivalent to 30% to 40% of average sales when expanding overseas. By eliminating these distribution fees, Samsung Bioepis (搜索) can substantially improve profitability while gaining greater control over pricing strategy and market positioning.
"Under the existing sales agency structure, revenue is shared, so recognized sales are lower," explained a senior Samsung Group executive who requested anonymity. "If we switch to direct sales starting with biosimilars that are established in the market, we can see the effect of increasing recognized sales in accounting."
Funding New Drug Development Pipeline
The strategic pivot comes as Samsung Bioepis (搜索) faces the critical task of generating sufficient cash flow to fund its expanding new drug development efforts. Following last year's spin-off from Samsung Biologics, the company operates under Samsung Bioepis Holdings (搜索) and has established EPIS NexLab (搜索) as a dedicated new drug R&D subsidiary.
Samsung Bioepis (搜索) submitted its first new drug pipeline to the U.S. Food and Drug Administration (FDA) at the end of last year—a phase 1 clinical trial plan for an antibody-drug conjugate (ADC) candidate for bladder cancer (搜索) developed through joint research with IntoCell (搜索). The company aims to enter global phase 1 trials this year.
The company has signed a joint research agreement with IntoCell (搜索) for up to five ADCs and agreed with China's Frontline to co-develop two ADC candidates. Additionally, Samsung Bioepis (搜索) has partnered with Seoul National University and PROTEINA (搜索) to discover 10 antibody new drug candidates by 2027.
Market Challenges and Competitive Landscape
The shift to direct sales comes amid intensifying competition in the global biosimilar market. The top eight corporations, including Switzerland's Sandoz, U.S. companies Pfizer and Amgen, Korea's Celltrion and Samsung Bioepis (搜索), India's Biocon, and U.S. company Biogen, account for approximately 70% of market sales.
Samsung Bioepis (搜索) faces particular challenges in maintaining its competitive position. In 2024, Celltrion's annual biosimilar sales reached 3.1 trillion won compared to Samsung Bioepis' 1.5 trillion won. Celltrion has operated direct sales networks in key markets from the beginning, enabling more aggressive and flexible strategies.
The company also confronts ongoing patent disputes. Samsung Bioepis (搜索) received FDA approval for the macular degeneration (搜索) treatment Eylea biosimilar Opzuviz (搜索) in May last year but lost an appeal regarding a preliminary injunction filed by original drugmaker Regeneron. Among biosimilar developers targeted by the lawsuit, only Amgen has been selling its product in the United States since November 2023.
Regulatory Environment and Future Outlook
The evolving regulatory landscape presents both opportunities and challenges. The U.S. Trump administration's drug price-cut policy, aimed at aligning U.S. drug prices with levels in other major advanced countries, could benefit biosimilar companies by encouraging adoption of cheaper alternatives to original drugs.
Regulatory agencies including the European Medicines Agency (EMA) and FDA are reviewing waivers of comparative clinical trials to reduce biosimilar development burdens, potentially improving business feasibility by cutting development costs and shortening timelines.
However, increased competition from Indian and Chinese biosimilar corporations pursuing low-price strategies raises concerns about profitability. "As biosimilar approval applications by Indian and Chinese corporations in the United States increase, competition is intensifying and concerns about worsening profitability remain," noted Lee Seung-gyu, vice chair of the Korea Biotechnology Industry Organization.
Samsung Bioepis (搜索) has launched nine products to date and plans to develop more than 10 additional biosimilars by 2030. With follow-on products including a Keytruda biosimilar expected to take at least three years to commercialize, maximizing sales of existing approved products has emerged as the key determinant of future investment capacity.
Kim Su-min, senior researcher at Korea Ratings, emphasized the strategic importance of the transition: "As biosimilar competition intensifies, securing first-mover status, building each corporation's portfolio, and strategies for market access, sales network acquisition, and expense structure management are becoming even more important."