In a move that underscores the accelerating consolidation of the global biosimilar market, Sandoz and Samsung Bioepis announced in March 2026 a new global license, development, and commercialization agreement covering up to five next-generation biosimilar candidates. The first asset in the expanded partnership is SB36, a biosimilar referencing Takeda's blockbuster inflammatory bowel disease (IBD) drug Entyvio (vedolizumab).
The two companies are no strangers. Their partnership began in 2023, when Sandoz secured commercial rights to Samsung Bioepis's Pyzchiva (ustekinumab), a biosimilar of Johnson & Johnson's Stelara. Pyzchiva launched in Europe in July 2024 and in the United States in February 2025, establishing a successful template for collaboration.
Under the new agreement, the division of responsibilities is clear and strategically significant. Samsung Bioepis retains responsibility for development, regulatory registration in key markets, and manufacturing. Sandoz gains exclusive commercialization rights globally, with the notable exception of China, Hong Kong, Taiwan, Macau, and South Korea — markets where Samsung Bioepis will maintain its own commercial presence.
This structure reflects a broader industry trend: development and manufacturing expertise concentrated in Asia, with commercialization powerhouses in Europe and North America driving market access. For API and intermediate suppliers, this model has direct implications for procurement volumes, quality standard expectations, and supply chain geography.
Entyvio is Takeda's flagship product, generating approximately $5.5 billion in annual global sales. The drug — a humanized monoclonal antibody targeting the α4β7 integrin — is approved for moderately to severely active ulcerative colitis and Crohn's disease. It is administered both intravenously and subcutaneously.
For biosimilar developers, vedolizumab presents a complex but commercially attractive target. The molecule requires sophisticated biologics manufacturing capabilities, including mammalian cell culture, purification of large glycoproteins, and rigorous comparability testing. These technical barriers mean that only a handful of global biosimilar manufacturers are positioned to compete — and Samsung Bioepis is firmly among them.
The entry of SB36 into late-stage development signals that the vedolizumab biosimilar market is approaching readiness. For API suppliers specializing in biologics intermediates — cell culture media, resins, and critical raw materials — this represents a significant new demand driver expected to materialize within the next 18 to 24 months.
While the companies have not publicly disclosed the identities of the remaining four biosimilar candidates covered by the agreement, industry observers have speculated on likely targets based on patent expiry timelines and therapeutic area alignment. Potential candidates could include biosimilars to:
Regardless of which specific molecules are ultimately included, the five-candidate framework gives both partners a structured pathway to compete across immunology, gastroenterology, and potentially ophthalmology — all areas of high unmet medical need and substantial biosimilar opportunity.
For B2B pharmaceutical suppliers, the Sandoz-Samsung Bioepis alliance carries several important signals:
1. Manufacturing Volume Concentration. Samsung Bioepis's continued role as the primary manufacturer means that its existing and planned biologics production sites — including its massive Songdo facility in Incheon — will drive demand for upstream raw materials. Suppliers of cell culture media, chromatography resins, and single-use bioreactor systems should anticipate increased procurement activity.
2. Quality Standardization. As Samsung Bioepis scales production across five biosimilar programs simultaneously, quality consistency becomes a strategic imperative. Suppliers who can demonstrate batch-to-batch reproducibility, regulatory-grade documentation, and robust supply continuity will be best positioned to win long-term contracts.
3. Geographic Diversification. The agreement's structure — Samsung Bioepis retaining Asian commercial rights while Sandoz covers the rest of the world — creates parallel supply chain requirements. Finished product must be available in both Western and Asian regulatory frameworks, each with its own stability testing, labeling, and packaging requirements. Contract packaging and logistics providers will find new opportunities in this dual-track model.
4. Competitive Pressure on Originators. Takeda and other originator companies facing biosimilar entry into their core franchises will intensify efforts to extend product life cycles through formulation innovation, new indications, and patient support programs. This creates secondary demand for novel delivery technologies, including pre-filled syringes, autoinjectors, and sustained-release formulations.
The Sandoz-Samsung Bioepis deal arrives during what many analysts are calling a "biosimilar super-cycle." Between 2024 and 2028, more than $200 billion in originator biologic sales face patent expiry across major global markets. Key molecules approaching loss of exclusivity include Keytruda (pembrolizumab, 2028 in the US), Opdivo (nivolumab), Eylea (aflibercept), and Stelara (ustekinumab).
This wave of patent cliffs is reshaping the pharmaceutical value chain from top to bottom. Originator companies are scrambling to fill revenue gaps through M&A and pipeline acceleration. Biosimilar developers are racing to establish manufacturing capacity and commercial infrastructure. And at the base of the pyramid, API and intermediate suppliers are seeing demand for complex biologics raw materials reach unprecedented levels.
The alliance between Sandoz and Samsung Bioepis is emblematic of this transformation. By combining Samsung Bioepis's development and manufacturing prowess with Sandoz's global commercial reach, the partnership is designed to capture a significant share of the biosimilar opportunity across multiple therapeutic areas.
As SB36 advances toward regulatory submission and the remaining four candidates in the alliance are disclosed, market participants across the pharmaceutical supply chain should be preparing now. For API and intermediate manufacturers, the message is clear: biosimilar-driven demand is no longer a future possibility — it is an unfolding reality with concrete timelines, substantial volumes, and exacting quality requirements.
Suppliers who invest today in capacity expansion, regulatory compliance, and partnership readiness will be best positioned to benefit from what promises to be one of the most significant structural shifts in the global pharmaceutical industry in the coming decade.
