Tagged as: Samsung Bioepis

Pfizer Files Lawsuit in Australia to Halt Sales of BRENZYS (etanercept)

Last week Pfizer filed a lawsuit in a federal court of Australia against respondents Samsung Bioepis, Merck, Sharp & Dohme, Organon, and Arrow, to halt sales of their biosimilar BRENZYS (etanercept).  Pfizer alleges that the respondents infringe Australian Patent No. 2005280034, titled “Production of polypeptides,” with claims directed to cell…

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Samsung Biologics Completes Full Acquisition of Samsung Bioepis

In January 2022, Biogen Inc. announced it had reached an agreement to sell its equity stake in the Samsung Bioepis joint venture to partner Samsung Biologics.  On April 20, 2022, Samsung Biologics and Biogen announced that Samsung Biologics has now fully acquired Samsung Bioepis for a total consideration of USD…

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Switching Study Concludes That Transition From Humira To Samsung Bioepis’s Adalimumab Biosimilar Is Safe and Effective

Results of the PROPER study, an interim analysis assessing the safety and efficacy of switching from Abbvie’s Humira to Samsung Bioepsis’s biosimilar adalimumab product, SB5, were presented last week at the European Crohn’s and Colitis Organization’s annual meeting.  SB5 received EU marketing authorization in August 2017.  According to the presentation, the…

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Samsung Bioepis Clinical Trial Updates

On December 8, Samsung Bioepis announced that it had presented the longest follow-up study results for a trastuzumab biosimilar in patients with HER2-positive early or locally advanced breast cancer.  The five-year study compared long-term survival rates of patients on SB3 (ONTRUZANT®, Samsung Bioepis’ biosimilar of Herceptin®) and Herceptin® (trastuzumab) from…

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Final Judgment and Order of Permanent Injunction Entered in Immunex v. Samsung Bioepis Etanercept Biosimilar Litigation

The New Jersey district court in the Immunex v. Samsung Bioepis BPCIA litigation entered a Final Judgment and Order of Permanent Injunction on November 3, 2021.  As we previously reported, the litigation pertains to ETICOVO (etanercept-ykro), Samsung Bioepis’s biosimilar of ENBREL.  The case had been administratively stayed since January 2020. Judgment…

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Recent Launches – Formycon, bioeq and Boryung, Samsung Bioepis

On August 5, 2021, Formycon and Bioeq announced submission of the biologics license application for FYB201 to the U.S. Food and Drug Administration.  FYB201 is a biosimilar candidate to Lucentis(R)1 (Ranibizumab), which is used in the treatment of neovascular (wet) macular degeneration and other serious eye diseases.  If approved, Coherus…

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Study Concludes Two Adalimumab Biosimilars may be as Safe and Effective as Originator

An article published last week in Scientific Reports describes the results of a multicenter prospective study evaluating the safety and efficacy of switching IBD patients from Abbvie’s Humira product to either of two adalimumab biosimilars, ABP501 (Amgen) and SB5 (Samsung Bioepsis).  The authors concluded from this study that both biosimilars…

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Samsung Bioepis Initiates Phase 1 Trial of Ustekinumab Biosimilar

Earlier today, Samsung Bioepis announced the initiation of a Phase 1 clinical trial for SB17, the company’s proposed biosimilar to Stelara® (ustekinumab).  The trial will compare the pharmacokinetics, safety, tolerability, and immunogenicity of SB17 and Stelara®.  With the start of this trial, Samsung Bioepis has the following biosimilar candidates in…

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Q4 2020 and Full Year Earnings Roundup: Biologics and Biosimilars Update

Below are some highlights from fourth quarter and full year 2020 earnings reports recently released by biologics and biosimilars companies: At the end of last month, Johnson & Johnson reported fourth quarter sales of $22.5 billion reflecting growth of 8.3% and full year sales of $82.6 billion reflecting growth of…

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