Samsung Bioepis is reshaping its approach to the global biosimilar market, shifting from a product development-centered model to one driven by commercialization strategy. The company is accelerating efforts to transform itself into a strategic architect of the biosimilar market. The move signals a shift beyond its traditional role as a "first mover" delivering high-quality drugs on time, toward building an integrated business model that directly designs distribution structures from the earliest stages of market entry.
According to industry sources on June 23, Samsung Bioepis recently adopted an early-stage collaboration model with global pharmaceutical company Sandoz, jointly preparing research and development alongside commercialization from the preclinical phase. This represents an evolution from the conventional approach of sales-focused partnerships formed only after product approval, toward an integrated model that co-designs clinical trial planning, regulatory strategy, and launch timing from the outset. Samsung Bioepis introduced this model because partnering from the development stage allows more precise coordination of market entry approaches, reducing development risk while maximizing the probability of commercial success.
The first target of this collaboration, SB36 (generic name: vedolizumab), is a biosimilar of the original drug Entyvio. Entyvio is a treatment for inflammatory bowel disease with global sales of approximately 9 trillion won ($6.6 billion), forming a massive market. Through this agreement, Samsung Bioepis has secured a foundation to expand its strategic partnership with Sandoz to up to five follow-on pipeline products including SB36. Analysts note the deal carries significant business value, as it goes beyond simply transferring distribution rights for a single product — it preemptively secures commercialization pathways for key pipeline candidates considered next-generation growth drivers from the early development stage. The approach of jointly discussing market entry strategies from the clinical design phase is expected to serve as a critical catalyst for dramatically shortening the time required for products to gain a foothold after launch.
Samsung Bioepis has been pursuing a strategy of securing diverse sales channels across products and regions even before product launches. The company is boosting market share by deploying a combination of approaches tailored to current market conditions and product characteristics: direct sales, partnerships, pharmacy benefit manager (PBM) formulary listings, private label (PL) supply, and early-stage collaboration.
These business strategies are producing concrete results in major markets including Europe and the United States. Europe is where results have emerged first. Starting with SB12, a biosimilar of the rare disease treatment Soliris, in 2023, Samsung Bioepis is now directly selling a total of four products. SB12 in particular held an overwhelming first-place position with a 54.4% share of the European eculizumab biosimilar market as of the end of last year. Partnership-driven results are also notable. SB17, a Stelara biosimilar developed in collaboration with Sandoz, holds the top position with a 34.4% share of the European ustekinumab biosimilar market.
In the U.S. market, Samsung Bioepis is running a "two-track" strategy combining PBM formulary listings with private label supply, reflecting the characteristics of the country's private insurance system. Last year, Samsung Bioepis simultaneously signed private label supply contracts for SB17 with Quallent, a subsidiary of Express Scripts — one of the three largest U.S. PBMs — and Coram CVS/Specialty Infusion Services (Cordavis), a subsidiary of CVS Caremark. Signing private label contracts with two of the top three PBMs simultaneously was a first in the biosimilar industry. Additionally, listing SB12 and SB17 as preferred drugs on the formulary of ESI, the largest U.S. PBM, is expected to accelerate market share gains. The company has secured stable prescription channels through a massive platform that accounts for approximately 30% of the total U.S. PBM market.
These moves are interpreted as a strategic response to a rapidly changing industry environment, breaking away from the past approach of relying solely on product development speed. The biosimilar market has recently seen a fast-shifting competitive landscape, with discussions on streamlining Phase 3 clinical trials gaining specificity and global competitors increasing their market entries. Drug price reduction pressures from various countries are adding to an increasingly challenging market environment. Ultimately, the ability to manage the entire process from initial product design through final distribution in an integrated manner has become a core competency determining corporate survival. Industry observers note that Samsung Bioepis has moved beyond simply developing and manufacturing drugs, building a business model that designs distribution structures tailored to market conditions.
"Recent biosimilar competition is transitioning beyond development speed into a battle of commercialization strategies," a Korean bio-industry official said. "Companies that can simultaneously design development and sales strategies are most likely to secure market leadership."
