BRIEF—Avastin biosimilar accepted for US review

Samsung Bioepis has announced that the US Food and Drug Administration has accepted for review the its Biologics License Application (BLA) under the 351(k) pathway for SB8, a biosimilar candidate referencing Avastin (bevacizumab).

The original product is a cancer treatment from the Swiss pharmaceutical giant, Roche, which had US sales of $2.9 billion in 2018.

If approved, SB8 will be commercialized in the USA by Merck & Co, a company known as MSD outside the USA and Canada.

Samsung Bioepis is a joint venture between the Korean company Samsung BioLogics and the US biotech firm Biogen