Samsung Bioepis is expanding its growth strategy beyond biosimilars into novel drug development. While broadening its portfolio of biosimilars in global markets, the company is also accelerating the development of antibody-drug conjugate (ADC) therapies as it seeks to diversify its business portfolio.
According to industry sources on Aug. 11, Samsung Bioepis’ current business foundation is its biosimilar portfolio. The company develops and supplies biosimilars across a range of therapeutic areas, including autoimmune diseases, ophthalmic diseases and cancer. Building on its accumulated development and regulatory experience, it is pursuing an expansion of follow-on products.
Samsung Epis Holdings is developing biosimilars of major blockbuster drugs including Keytruda, Dupixent, Tremfya, Taltz, Enhertu, Entyvio and Ocrevus, and has set a goal of expanding its biosimilar portfolio to 20 products by 2030.
The market environment is also becoming more favorable for biosimilar growth. The U.S. Food and Drug Administration has lowered user fees related to biosimilars, potentially easing the regulatory cost burden on developers.
As the world’s largest pharmaceutical market, lower development and regulatory costs in the United States are expected to support broader market entry for biosimilars.
Samsung Bioepis is also positioning the United States as a key growth market, pursuing expanded prescriptions for existing products while preparing to launch follow-on products. The company aims to broaden its market presence by simultaneously expanding sales of existing products and securing new pipeline assets.
Another notable shift in the company’s recent strategy is its expansion beyond biosimilars into novel drug development.
Samsung Bioepis recently signed a definitive agreement with Intocell for the further research and development and commercialization of the ADC candidate SBE303. The two companies previously collaborated to identify ADC drug candidates, and the latest agreement expands their partnership to include the further development and commercialization of their first candidate.
SBE303 is an ADC candidate targeting Nectin-4 and is currently undergoing a global Phase 1 clinical trial. ADCs combine an antibody targeting a specific antigen with a drug to selectively deliver the drug to cancer cells and are considered one of the next-generation cancer treatment technologies.
The agreement is significant in that Samsung Bioepis is establishing a development model in which it identifies novel drug candidates through joint research with external biotech companies and advances them through clinical development and commercialization.
The company’s accumulated expertise in antibody research and development, as well as its global clinical and regulatory experience gained through biosimilar development, could also be leveraged in novel drug development.
Samsung Epis Holdings Strengthens Novel Drug and Biotech Strategy After Launch
The shift is part of a broader portfolio restructuring strategy following the launch of Samsung Epis Holdings. The holding company plans to maintain biosimilars as its core business while developing novel drugs and next-generation therapeutic technology platforms as new growth engines.
Samsung Bioepis’ growth strategy can be broadly divided into a two-track approach centered on biosimilars and novel drugs. In biosimilars, the company aims to strengthen its stable growth base through expanded global sales and additional pipeline products. In novel drugs, it seeks to create new growth opportunities through next-generation therapies such as ADCs.
However, the success of novel drug development can vary significantly depending on clinical outcomes and regulatory approvals. As a result, the clinical performance of candidates including SBE303 is expected to be an important variable going forward.
An industry source said, “There is significant interest in how successfully Samsung Bioepis can apply the development, regulatory and commercialization experience it has accumulated in the biosimilar market to novel drug development.” The source added, “If the company can secure both the growth potential of its existing biosimilar business and the future growth potential of its novel drug pipeline, its business portfolio could expand beyond its traditional focus on biosimilars.”