Celltrion trio rally upon FDA’s marketing approval of Avastin biosim in U.S.

2022.09.29 10:59:00 | 2022.09.29 11:43:38

[Source: Celltrion]이미지 확대

[Source: Celltrion]

Celltrion trio stocks rallied Thursday morning on news that the Korean biosimilar giant has gained approval for its recombinant monoclonal antibody Vegzelma referencing Roche’s best-selling cancer drug Avastin (bevacizumab) from the U.S. Food and Drug Administration.

Celltrion shares added 3.00 percent to trade at 171,500 won ($119.74) on Thursday morning, while its marketing arm Celltrion Healthcare added 4.21 percent to 66,800 won and drug developer and manufacturer Celltrion Pharm 3.61 percent to 63,100 won.

Vegzelma codenamed CT-P16 is indicated for the treatment of metastatic colorectal cancer, non-small cell lung cancer, metastatic renal cell cancer, cervical cancer, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and circulating glioblastoma.

The FDA clearance followed marketing approvals in Europe in August and in Britain and Japan this month.

The Korean biosimilar giant also announced in a separate filing on Wednesday that Vegzelma also gained approval from Korea’s Ministry of Food and Drug Safety.

Avastin is one of the best-selling cancer drugs in the world, with global sales of $5.4 billion, and it is the best-selling product for Roche, whose subsidiary Genentech makes it.

Celltrion reached out-of-court settlement over a patent dispute with Genentech in May to remove legal hurdles to the global launch of Vegzelma.

Celltrion will begin global sales of the drug through its Celltrion Healthcare unit, starting from Europe in the fourth quarter. According to IQVIA data, bevacizumab sales amounted to $6.43 billion globally last year. The U.S. is the largest bevacizumab market.

By Chung Seul-gi and Minu Kim

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