New White Paper Highlights Barriers and Opportunities to Drive Biosimilar Adoption in the United States
November 17, 2021 07:00 ET | Samsung Bioepis
Healthcare professionals can benefit from more education to address knowledge gaps about the FDA’s robust evaluation, review, and approval standards for biosimilarsDo prescribers and patients benefit...
FDA Approves Samsung Bioepis and Biogen’s BYOOVIZ™ (SB11), LUCENTIS® Biosimilar (ranibizumab-nuna)
September 20, 2021 07:30 ET | Samsung Bioepis
BYOOVIZ™ becomes the first ophthalmology biosimilar to gain FDA approval in the United States  INCHEON, Korea and CAMBRIDGE, Mass., Sept. 20, 2021 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and...
Samsung Bioepis Announces Five-year Follow-up Results for ONTRUZANT® (trastuzumab) in Early or Locally Advanced HER2 Positive Breast Cancer at the European Society for Medical Oncology (ESMO) Virtual Congress 2021
September 12, 2021 18:05 ET | Samsung Bioepis
Five-year follow-up results show comparable cardiac safety profile and long-term efficacy between biosimilar ONTRUZANT® (trastuzumab) and reference medicine HERCEPTIN® i (trastuzumab) in early or...
A Post-hoc Analysis of Phase 3 Study Demonstrates Baseline Factors Associated with Visual Acuity and Anatomical Outcomes of Samsung Bioepis’ BYOOVIZ™ (Ranibizumab) in nAMD at the EURETINA 2021
September 09, 2021 06:00 ET | Samsung Bioepis
The post-hoc analysis shows that baseline age, best corrected visual acuity (BCVA), central subfield thickness (CST), and total lesion size were identified to be associated with the visual acuity and...
Samsung Bioepis Announces Analytical Similarity Data on SB11 (ranibizumab) at the ARVO Annual Meeting 2021
May 01, 2021 07:01 ET | Samsung Bioepis
Analytical assessment demonstrates structural, physicochemical, and biological similarity between SB11 and Lucentis SB11 is under review by the FDA and EMA INCHEON, Korea, May 01, 2021 (GLOBE...
Samsung Bioepis Continues Global Market Expansion with Launch of HADLIMA™ in Australia and Canada in partnership with Merck & Co.
March 29, 2021 05:30 ET | Samsung Bioepis
Samsung Bioepis broadens its global reach by launching HADLIMA™ in Australia and in Canada, both in partnership with Merck & Co.Samsung Bioepis’ adalimumab is now available in three markets:...
[Image] Samsung Bioepis' New Headquarter in Songdo
Samsung Bioepis Opens the New State-of-the-Art Headquarters to Accommodate Next Stage of Growth and Innovation
January 25, 2021 06:00 ET | Samsung Bioepis
Located in Korea’s ‘Bio Cluster’ of Songdo in the Incheon Free Economic Zone (IFEZ) The 52,000-square-foot campus to become the hub of Samsung Bioepis’ drive for accelerated development of...
Samsung Bioepis Announces First Real-World Data on RENFLEXIS® (infliximab-abda) with IBD patients from Veterans Affairs Healthcare System at the American College of Gastroenterology (ACG) 2020
October 26, 2020 08:00 ET | Samsung Bioepis
Switching from reference infliximab or infliximab-dyyb to RENFLEXIS® (infliximab-abda) demonstrated comparable efficacy and safety in IBD patients registered to VA Healthcare SystemContinuation rates...
Samsung Bioepis Receives European Commission Approval for AYBINTIO® (Bevacizumab)
August 20, 2020 04:47 ET | Samsung Bioepis
AYBINTIO® is approved for the treatment of the same types of cancer as reference bevacizumab (AVASTIN®i)AYBINTIO® is Samsung Bioepis’ fifth biosimilar to be approved by the European Commission ...
Samsung Bioepis Receives Positive CHMP Opinion for AYBINTIO® (Bevacizumab)
June 26, 2020 07:12 ET | Samsung Bioepis
AYBINTIO®, a biosimilar candidate referencing Avastin®i (bevacizumab), is Samsung Bioepis’ second oncology biosimilar to be recommended for marketing authorization by the European Medicines...