Here’s the latest I can share about Samsung Bioepis based on recent public releases:
SB3 trastuzumab biosimilar: The FDA accepted SB3 for review under the 351(k) pathway. If approved, Merck/MSD would handle U.S. commercialization. This marks Samsung Bioepis’ first oncology biosimilar candidate to enter U.S. regulatory review. [Source: Business Wire via Ritzau press release, 2026-02-25][2]
SB5 adalimumab biosimilar: FDA accepted for review Samsung Bioepis’ SB5, a candidate referencing Humira, signaling continued progression of their immunology biosimilar portfolio in the U.S. market. [Source: Business Wire via Ritzau press release, 2025-04-01][1]
Other activity: Samsung Bioepis has an ongoing pipeline that includes ophthalmology biosimilars (e.g., bevacizumab references) and additional immunology candidates, with frequent updates on regulatory progress, trial initiations, and market strategy across regions. Examples include prior phase 3 programs and regulatory activities in Europe and the U.S. noted in GlobeNewswire and corporate announcements. [Sources include GlobeNewswire listings and corporate news pages, 2024–2025][3][4][5]
If you’d like, I can:
Would you like me to proceed with a focused summary on SB3 and SB5, or broaden to the full latest biosimilars pipeline?
Citations:
samsung bioepis Latest Breaking News, Pictures, Videos, and Special Reports from The Economic Times. samsung bioepis Blogs, Comments and Archive News on Economictimes.com
economictimes.indiatimes.comGlobeNewswire specializes in the distribution and delivery of press releases, financial disclosures and multimedia content to the media and general public.
www.globenewswire.comFDA • Samsung Bioepis expands partnership with Biogen for two ophthalmology biosimilar candidates in the US, Canada, Europe, Japan, and Australia • Samsung Bioepis’ trastuzumab biosimilar becomes the first biosimilar to gain World Health Organization (WHO) prequalification status • Samsung Bioepis' bevacizumab biosimilar receives EC approval SB_2020_04_03_37_P 2021 • Samsung Bioepis moves into the new office located in Songdo, Korea • Bevacizumab biosimilar approved by MFDS
www.samsungbioepis.comSamsung Biologics’ Statement on recent media reportsregarding the Samsung Biologics’ IPO Samsung Biologics has prepared a statement regarding recent reports
samsungbiologics.comSamsung Bioepis is a biopharmaceutical company focused on increasing patient access to high-quality medicines through the development of biosimilars.
www.samsungbioepis.comSamsung Bioepis' Biologics License Application for SB5 Adalimumab Biosimilar Candidate Accepted for Review by the U.S. Food and Drug Administration
via.ritzau.dkGlobeNewswire specializes in the distribution and delivery of press releases, financial disclosures and multimedia content to the media and general public.
www.globenewswire.comSamsung Bioepis' SB3 Trastuzumab Biosimilar Candidate Accepted for Review by the US Food and Drug Administration
via.ritzau.dkSamsung Bioepis is a biopharmaceutical company focused on increasing patient access to high-quality medicines through the development of biosimilars.
www.samsungbioepis.com