The clock has started ticking for the approval process of Samsung Bioepis’ fifth biosimilar in the US.

The company said Wednesday that the US Food and Drug Administration has agreed to review the license application it submitted in September for SB8, a biosimilar candidate referencing Avastin (bevacizumab). 

Avastin is a blockbuster biologics drug of Roche that prevents tumor growth by blocking blood supply. It inhibits a protein called vascular endothelial growth factor that creates new blood vessels. While normal cells also make VEGF, some cancer cells make too much of it leading to metastasis. By stumping VEGF, Avastin can starve the tumor.

Avastin’s yearly global revenue in 2018 amounted to 6.8 billion Swiss franc ($6.9 billion) -- of which the US market took up 42 percent at some 2.9 billion Swiss franc. The drug’s patent expires in the US in 2019 and in Europe in 2022.

Biosimilars referencing Avastin are anticipated to offer more affordable treatment options for patients and growth momentum for related companies.

Merck, known as MSD outside the US and Canada, will commercialize SB8 in the US if it gains approval.

Bioepis currently has the FDA’s green light for commercialization of Remicade biosimilar Renflexis (infliximab), Enbrel biosimilar Eticovo (etanercept), Humira biosimilar Hadlima (adalimumab) and Herceptin biosimilar Ontruzant (trastuzumab).

Bioepis CEO Ko Han-sung said earlier this month that he expects 2019 to mark the company’s first-ever profit since foundation in 2012.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)