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Samsung Bioepis Begins US Approval Process for SB8 Biosimilar


Between 2019.11.20 17:25

Samsung Bioepis office building. Provided by Samsung Bioepis

Samsung Bioepis will sell Avastin biosimilars in the US market.

Samsung Bioepis announced on the 20th that the US Food and Drug Administration (FDA) has begun reviewing the ALABEST biosimilar SB8 (bevacizumab ingredient name) biopharmaceuticals (BLA) application.

Avastin is a treatment for tumor diseases sold by global pharmacy Roche. It has indications for metastatic colorectal cancer and non-small cell lung cancer. Avastin's annual global sales totaled CHF 6.849 billion (about 820 trillion won) from last year. Among them, sales in the US market are 2.94 billion Swiss francs (about 3.5 trillion won), representing 42% of the total.

Samsung Bioepis sells Renflexis, a biosimilar medicine, in the USA. The company obtained the license to sell Eticobo (Enbrel Biosimilar), Hadlima (Humira Biosimilar) and Ontruxant (Herceptin Biosimilar).

In July, SB8 applied for a European marketing license and is the first Korean company to sell Avastin biosimilars. In September, he attended the European Society of Oncology Regular Conference (Congress ESMO 2019) in Barcelona, ​​Spain to unveil the results of the SB8 clinical trial for the first time.

Samsung Bioepis has demonstrated the equivalence of patients' risk response ratio (ORR) to the parent drug based on SB8 phase 3 clinical trials in 763 non-small cell lung cancer (NSCLC) patients.

A Samsung Bioepis official said, "We will try to prove the company's R&D capabilities in the US SB8 marketing authorization review process and ensure opportunities for multiple product portfolios in the future."

Meanwhile, Samsung Bioepis has recently strengthened its cooperation in marketing partnerships to enter the global biosimilar market and is expanding biosimilar research and development in many areas, in addition to existing autoimmune and tumor diseases.

Treatment for rare diseases SB12 (Soliris Biosimilar) is currently in a Phase III clinical study. Therapeutic agents for ophthalmic diseases SB11 (Rucentis biosimilar ingredient, Ranibizumab) and SB15 (Ilia biosimilar ingredient, Applevercept) are also currently in phase 3 of clinical trials and preparations.

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