For biosimilar industry watchers like BR&R, Samsung Bioepis has played a leading role in introducing biosimilars to the US market, first with its infliximab biosimilar Renflexis. Over the years, as their biosimilar candidates were approved by the FDA, the pipeline appeared to thin, with pembrolizumab (SB27) being the sole publicly disclosed biosimilar candidate, as of the beginning of this week.
That changed very suddenly on January 15, when Samsung Epis Holdings, the parent of Samsung Bioepis, announced a healthy new slate of biosimilar candidates in early-stage development. The six additions to the pipeline include:
- Dupilumab (reference product, Dupixent) (earliest main patent expiration, 2031)
- Guselkumab (Tremfya) (2031)
- Ixekizumab (Taltz) (2030)
- Vedolizumab (Entyvio) (2028)
- Ocrelizumab (Ocrevus) (2029)
- Fam-trastuzumab deruxtecan (Enhertu) (2033)
When queried by E-mail, Samsung Bioepis added that each of these biosimilar candidates were developed in-house and were not licensed from other biopharmaceutical companies.
In the announcement, Kyung-Ah Kim, President and CEO of Samsung Epis Holdings, stated, “We are making great progress to secure 20 biosimilars in our portfolio by 2030.”
In addition to the newly announced biosimilar pipeline, Samsung Bioepis also updated its efforts to produce novel therapeutics. These include an antibody conjugate (SBE303) for oncology indications, which is entering phase 1 trial. This investigational innovator agent was partly the result of a global partnership with Phrontline Biopharma. The company intends to introduce “one novel therapeutic candidate into clinical study every year.”
(Editor’s Note: The anticipated patent expiration dates are obtained through multiple sources, based on composition-of-matter patents. However, patent litigation that delays commercialization may extend beyond these principal patents.)
