Samsung Bioepis has begun reviewing documents for the SB8 (Avastin Biosimilar, ingredient name Bevacizumab) in the Food and Drug Administration (FDA). He said 20 days.
Document review initiated by Samsung Bioepis submission of an initial review of the application submitted in September, which means that the FDA has started a full assessment of the marketing authorization of the product.
Avastin is a cancer drug sold by Roche in Switzerland and has indications for metastatic colorectal cancer and non-small cell lung cancer. In 2018, Avastin's annual global sales totaled 6.89 billion Swiss francs (approximately 8.2 trillion winnings), of which sales on the US market amounted to 2.94 billion Swiss franc (approximately 3.5 trillion winnings), representing 42% whole.
Samsung Bioepis currently sells Renflexis (Remicade Biosimilar) for autoimmune diseases in the United States, Eticovo (Enbrel Biosimilar), Hadlima (Humilima Biosimilar), Ontruzant (Herceptin biosimilar medicine) received for the treatment of cancer.
SB8 is the fifth biosimilar medicine and the second cancer medicine Samsung Bioepis, which will be presented on the world market. In July, SB8 was the first Korean company to apply for Avastin biosimilars.
In September, he participated in the ESMO 2019 competition in Barcelona, Spain, where he published his first clinical results of SB8.
According to the results, a Phase III SBI8 clinical trial in 763 patients with non-small cell lung cancer (NSCLC) showed that Samsung Bioepis had a "best overall response" risk ratio. Equivalence has been proven.
An official from Samsung Bioepis said: "We will try to prove the company's R&D capabilities in the US SB8 license review process and prepare for different product portfolios in the future."