At the J.P. Morgan Healthcare Conference on 14 January 2026, Samsung Epis Holdings announced the addition of six biosimilar candidates to Samsung Bioepis’ pipeline: dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab.
The announcement confirms the November 2025 report that Samsung Bioepis had commenced development of a biosimilar to AstraZeneca/Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan), with the biosimilar in the early development stage in preparation for preclinical trials. The same report had also indicated that Samsung Bioepis is developing biosimilars to Regeneron/Sanofi’s Dupixent® (dupilumab), Janssen’s Tremfya® (guselkumab) and Eli Lilly’s Talz® (ixekizumab).
Samsung Bioepis has launched 11 biosimilars to 10 INNs on market around the world and has a biosimilar to MSD’s Keytruda® (pembrolizumab), (SB27) in phase 1 and 3 clinical trials (commenced April 2024). The company is aiming to have 20 biosimilars in its portfolio by 2030.
At the J.P. Morgan Conference, Samsung Epis also announced that the FDA has approved Samsung Bioepis’ investigational new drug application (IND) for SBE303, an antibody-drug conjugate, which is expected to enter a Phase 1 first-in-human clinical trial in patients with advanced refractory solid tumours this year.
There are a number of companies with dupilumab biosimilars under development. In August 2025, CSPC Pharmaceutical announced that it received approval from China’s National Medical Products Administration (NMPA) to conduct clinical trials of its dupilumab injection. In June 2025, Bio-Thera Solutions and Costa Rican-based SteinCares announced an agreement to commercialise biosimilar dupilumab across Latin America, with Bio-Thera responsible for product development and supply, and SteinCares responsible for commercialisation. Alvotech and Advanz entered into partnership agreements in February 2023, May 2023 and June 2024 for the commercialisation of various biosimilars, including dupilumab, in Europe and certain other countries.
Biosimilar development of guselkumab is also underway. In September 2025, Polpharma and MS Pharma announced that they entered into a licensing agreement for the commercialisation of PB019, biosimilar guselkumab, in the MENA region. In 2023, Alvotech and Advanz Pharma entered into a partnership agreement to commercialise a proposed guselkumab biosimilar in the EU, UK and Switzerland.
Biosimilars to Takeda’s Entyvio® (vedolizumab) are in development by at least Alvotech (Phase 3 clinical trial for AVT16 commenced September 2024), Intas Pharmaceuticals (approval from India’s CDSCO for a Phase 1 bioequivalence study of INTP53 obtained in February 2025) and Polpharma Biologics (which entered into licensing agreements with Fresenius Kabi and MS Pharma for commercialisation of PB016 in August and September 2025).
Ocrelizumab biosimilars (referencing Roche’s Ocrevus®) are in clinical trials sponsored by Biocad (Phase III, enrolment commenced November 2025), Sandoz (comparative pharmacokinetic trial underway), Amgen (Phase III trial reported in January 2025) and Celltrion (Phase III IND for CT-P53 partially approved by the EMA in August 2023).