Samsung's Dual Gambit: From Biosimilar Titan to Novel Drug Innovator

INCHEON, Korea – January 14, 2026 – Samsung Epis Holdings has signaled a dramatic and ambitious strategic pivot, leveraging its established dominance in the biosimilar market to fund a major foray into the high-stakes world of novel drug development. In a series of significant updates at the 44th J.P. Morgan Healthcare Conference, the company announced a major expansion of its biosimilar pipeline alongside the critical advancement of its first-ever novel therapeutic candidate, an antibody-drug conjugate (ADC) for cancer, into clinical trials.

The move positions the South Korean biopharmaceutical holding company to compete on two fronts: continuing to drive down healthcare costs with affordable biologic alternatives while simultaneously pursuing cutting-edge, first-in-class treatments for diseases with high unmet needs. The strategy was laid bare by President and CEO Kyung-Ah Kim, who framed 2026 as the start of "a new chapter" for the company.

The Biosimilar Bedrock Expands

Samsung Bioepis, the company's biopharmaceutical arm, solidified its foundation by unveiling six new candidates for its biosimilar pipeline. The new targets include copies of blockbuster drugs like Dupixent (dupilumab), Entyvio (vedolizumab), Tremfya (guselkumab), Taltz (ixekizumab), Ocrevus (ocrelizumab), and the complex ADC Enhertu (fam-trastuzumab deruxtecan-nxki).

This expansion is part of an aggressive plan to nearly double its portfolio. "We are making great progress to secure 20 biosimilars in our portfolio by 2030," stated Kim in the company's official announcement. This builds on an already formidable base of 11 approved biosimilars launched in over 40 countries, tackling major immunology, oncology, and ophthalmology markets.

The selection of targets like vedolizumab is particularly strategic. The reference drug, Takeda's Entyvio, is a market leader for inflammatory bowel disease, with key patents set to expire in the U.S. and Europe between 2027 and 2028. By advancing its own version, Samsung is positioning itself to capture a significant share of a multibillion-dollar market as soon as exclusivity ends, a playbook it has executed successfully with biosimilars for drugs like Humira and Enbrel. This reliable, revenue-generating engine of biosimilars appears to be the financial and operational bedrock upon which the company is building its more audacious innovative ambitions.

A Bold Leap into the ADC Arena

The most striking part of the announcement was the revelation that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for SBE303, Samsung Bioepis’ first novel therapeutic. SBE303 is an antibody-drug conjugate (ADC) engineered to target Nectin-4, a protein highly expressed on the surface of various tumor cells—including urothelial, lung, and breast cancers—but minimally present in healthy tissue.

ADCs are often described as "biological missiles," designed to deliver a potent chemotherapy payload directly to cancer cells while sparing healthy ones. This field has become one of the hottest areas in oncology, commanding multi-billion dollar valuations and intense competition.

By targeting Nectin-4, Samsung is entering a validated but competitive space. The target was first proven clinically and commercially viable by Seagen and Astellas's Padcev (enfortumab vedotin), an ADC that has transformed the treatment landscape for advanced urothelial cancer. Samsung's SBE303 will now aim to carve out its own place. A Phase 1 first-in-human clinical trial is scheduled to begin this year in the U.S. and Korea to evaluate the drug's safety and preliminary efficacy in patients with advanced solid tumors.

"As we broaden our portfolio beyond biosimilars, we will continue our development efforts in antibody-drug conjugates (ADCs), leveraging our innovative research and development platform to expand viable treatment options for patients with unmet needs,” Kim noted. This move from copying existing biologics to creating novel ones from scratch represents a fundamental evolution in the company's identity and R&D capabilities.

Building the Platforms for Future Innovation

Samsung's ambition doesn't stop with a single ADC. The company also signaled a long-term commitment to sustained innovation, stating a goal to advance one new novel therapeutic candidate into clinical studies every year.

Underpinning this vision is the work of Epis NexLab, a new subsidiary established in 2025. Epis NexLab has launched a project to develop a peptide-based drug delivery platform. Peptide therapeutics hold immense promise due to their high specificity, but they are notoriously difficult to administer, often requiring injections due to their instability in the digestive system.

Developing a novel platform to overcome these hurdles—potentially enabling oral or other non-invasive delivery methods—would be a significant technological breakthrough. It would not only support Samsung's own future drug pipeline but could also become a valuable platform technology to be licensed across the industry. This investment in foundational technology indicates a strategy focused not just on individual products, but on building core capabilities that can generate value for years to come.

A Calculated Gambit on the Global Stage

Announced against the backdrop of a J.P. Morgan Healthcare Conference buzzing with renewed biotech optimism and a focus on strategic growth, Samsung's dual-pronged strategy appears both timely and calculated. The company is effectively using its deep expertise and steady cash flow from the predictable biosimilar market to de-risk its entry into the volatile but potentially far more lucrative world of novel drug discovery.

This synergistic model allows the company to walk a tightrope that few can manage: simultaneously driving market access and affordability with its biosimilars while chasing the next generation of medical breakthroughs. The expertise gained in complex protein engineering, manufacturing, and navigating global regulatory pathways for its biosimilars provides a powerful launchpad for its novel programs.

The journey from a highly successful biosimilar developer to a fully integrated biopharmaceutical innovator is fraught with challenges, requiring massive investment and a tolerance for the high failure rates inherent in novel R&D. However, with a robust biosimilar pipeline to ensure stability and a clear, ambitious plan for its novel assets, Samsung Epis Holdings is making a powerful statement that it intends to be not just a market follower, but a future leader in shaping therapeutic innovation.