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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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 ...
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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...