Samsung Bioepis acquires European sales license for anticancer drug'Avincio (SB8)'
Avastin' biosimilar final approval in Europe...?Regional sequential release plans
- public when founding the pipeline five kinds (?) both obtained marketing authorization in the European market
piece for Samsung Bio (NYSE: High Han Seung CEO) of the European Commission (EC: European Commission) from "this blank It?was announced on the 21st that it has obtained the final marketing approval?for'AYBINTIO???, Avastin biosimilar, project name SB8, ingredient name bevacizumab' in Europe.
This was done two months after receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) in June. Epis is the first Korean company?to obtain approval for the sale of a biosimilar'AVASTIN???'.
'Avastin' is a blockbuster biopharmaceutical sold by Roche, Switzerland, and has indications for metastatic colon cancer and non-small cell lung cancer in the European market.
Avastin's global market sales last year amounted to about?8.5 trillion won1?)?(7,73 million Swiss francs), of which sales in the European market amounted to about 2.2 trillion won (1,694 billion Swiss francs).
Due to the approval of the European marketing license for'Avincio', Samsung Bioepis achieved sales approval for all five pipelines for treatment of autoimmune diseases and tumor diseases, which were unveiled at the time of establishment in 2012. As a company that independently developed Miller, it has become the company with the most product licenses in the European market.
Samsung Bioepis President Han-Seung Koh said, ?By securing the fifth biosimilar in the global market, we have laid the foundation for a leap forward as an industry leader. We will further expand our opportunities.?
Samsung Bioepis is currently in the European market with'BENEPALI???, Enbrel biosimilar','IMRALDI???. Humira biosimilar', and'FLIXABI???, Remicade biosimilar'. 'on True janteu `(ONTRUZANT???, Herceptin biosimilar), which sells, partner MSD (US Merck) Europe, the top five countries through: sequentially in (EU5 Germany, Britain, France, Italy, Spain) It is planning to sell'Abincio'.
In addition, the results of phase 3 clinical trials of'Abincio' were recently announced at the regular academic conference of the European Oncology Association (ESMO cogress 2019), and a study analysis of 763 non-small cell lung cancer (NSCLC) patients was studied. Through this,?the equivalence in terms of?risk ratio of best ORR?2)?compared to the original drug?has been demonstrated.
In November of last year, the approval review of the Biologics License Application (BLA) submitted to the Food and Drug Administration (FDA) was initiated (filing accepted). Entry into the US market is also visible.
Meanwhile, Samsung Bioepis is spurring the development of subsequent biosimilars in addition to treatments for autoimmune diseases and tumor diseases, and currently SB11 (Lucentis biosimilar, ingredient name ranibizumab) and SB15 (Ilia biosimilar, ingredient name) Aflibercept), blood disease treatment SB12 (Soliris biosimilar, ingredient name eculizumab), a total of eight biosimilar pipelines.?3)
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1) Original drug sales performance exchange rate applied
: As of the end of 2019, KEB Hana Bank announced trading standard rate (KRW 1,195.45)
2) best ORR (overall response rate)
: ?The best?overall response rate??,
the proportion of patients who showed tumor reduction beyond a predetermined range during a specific period
