Celltrion wins sales approval for biosimilar Vegzelma in Japan

Celltrion Inc. secured Japan’s approval for sales of its cancer treatment biosimilar CT-P16, a move to help the South Korean biopharmaceutical giant expand its market presence in Asia.

Celltrion said on Tuesday it has won permission from the Ministry of Health, Labor and Welfare to sell Vegzelma, referencing Avastin of Genentech Inc., a unit of global healthcare behemoth Roche Group. Japan is the world’s second-largest prescription drugs market for Avastin and its biosimilars, following the US.

Vegzelma is a medication used to treat a number of types of cancers, including metastatic breast cancer, non-small cell lung cancer, colorectal, renal cell, ovarian and cervical cancer.

“We plan to accelerate our expansion of the drug’s market share in Asia with the entry into Japan,” said a Celltrion official. “We will also further strengthen our cancer treatment biosimilar portfolio.”

Celltrion has been a major player in Japan as its Herzuma, a biosimilar of Roche's breast cancer medicine Herceptin, dominated the market with a 54% market share in the first quarter, according to pharmaceutical market research firm IQVIA.

The South Korean drugmaker earlier obtained sales approval for Vegzelma from the European Commission and the UK.

The company, which is seeking such permission from South Korea and the US, expected authorities of those countries to give a nod to the treatment within this year.

Write to Jae-Young Han at jyhan@hankyung.com
Jongwoo Cheon edited this article.