Celltrion gains sales approval for biosimilar Vegzelma in Europe

Celltrion Healthcare Co., South Korean biopharmaceutical giant Celltrion Inc.'s global marketing affiliate, said on Friday it has obtained the European Commission’s sales approval for its cancer treatment biosimilar CT-P16.

The EC approval of the drug, referencing Genentech Inc.’s Avastin, follows the recommendation for marketing authorization in June by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

CT-P16, to be sold under the brand name Vegzelma, will be Celltrion’s third oncology biosimilar approved by the EC, following two other products already available in Europe – Truxima, a blood cancer treatment, and breast cancer medication Herzuma.

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.

“With proven similarities in efficacy and safety compared to the reference product Avastin, Vegzelma will be available to treat some of the most commonly diagnosed cancers, which collectively affect hundreds of thousands of European patients each year,” said Kevin Byoung Seo Choi, senior vice president and head of marketing at Celltrion Healthcare.

Celltrion has also filed for regulatory approval with the US Food and Drug Administration (FDA) and the Korean Ministry of Food and Drug Safety. Approval is expected during the third quarter, according to the company.

SALES VIA ITS OWN CHANNELS

The company said in May it will expand direct sales, currently limited to a couple of drugs, to all products it sells in the European market to improve profitability.

In Europe, the company currently sells five biosimilar products.

It launched Remsima, a treatment for autoimmune diseases, via a local partner in 2013, but started to directly sell the biosimilar in 2019.

Celltrion has been directly selling Remsima SC, a subcutaneous injection type, and Yuflyma, a biosimilar of arthritis treatment Humira, since their European launches in 2020 and 2021, respectively.

The Korean biosimilar maker also plans to sell its new products via its own marketing vehicles in the US market.

According to market research firm IQVIA, the global Avastin market is worth 8.5 trillion won ($6.4 billion), of which the European market is estimated at 2 trillion won. The US Avastin market is worth 3.5 trillion won.

In the Avastin biosimilar segment, Pfizer Inc., Amgen Inc., Samsung Bioepis Co. and Viatris Inc. all entered the market ahead of Celltrion.

Write to Jae-young Han at jyhan@hankyung.com
In-Soo Nam edited this article.