Celltrion’s Herzuma is looked at by FDA

The U.S. Food and Drug Administration on July 28 accepted a biologics license application for Herzuma, a cancer treatment from Celltrion. [CELLTRION]

Celltrion, a leading biopharmaceutical firm, said Monday the U.S. Food and Drug Administration (FDA) on July 28 accepted a biologics license application (BLA) for its cancer treatment Herzuma.

The Songdo, Incheon-based company submitted the BLA for its biosimilar drug in May and the U.S. FDA accepted it after 60 days of review. A final decision on a license to sell the drug is scheduled to be made by the first half of next year.

Herzuma is a biosimilar version of trastuzumab, known by its brand name Herceptin, patented by Swiss drug firm Roche. Herceptin is a blockbuster drug with sales of 7.7 trillion won ($6.9 billion) worldwide last year. Within the United States alone, revenue from the single product was 3.48 trillion won.

Biosimilars, according to the FDA, are biological products that are approved based on proof that they are highly similar to other FDA-approved products. The drugs have no clinically meaningful differences in terms of safety or effectiveness from the reference product, but they cost less.

Biosimilars play a similar role in the marketing and sales of biological products, which use living cells, as generics do for chemical-based drugs.

Herzuma was approved in Korea in January 2014 for the treatment of early and advanced breast cancer and advanced stomach cancer. It is scheduled to begin domestic sales in the latter half of this year after clinical tests.

For sales abroad, Celltrion applied to the Ministry of Health, Labour and Welfare in Japan for approval to sell Herzuma in April and the company is also seeking permission from the European Medicines Agency.

Just a month ago, Celltrion filed an application in the United States for a review of a BLA for Truxima. Used in the treatment of a number of diseases, including rheumatoid arthritis and non-Hodgkin’s lymphoma, the drug began sales in Germany in May, three months after the European Medicines Agency (EMA) accepted Celltrion’s application. Sales in other European countries are expected to follow.

Should Herzuma and Truxima obtain approval in the United States, Celltrion will have three biosimilar products selling in the world’s biggest pharmaceutical market.

One drug already being marketed is Remsima, a treatment for autoimmune diseases such as rheumatoid arthritis, inflammatory bowel diseases and Crohn’s disease that received permission from the U.S. FDA in April last year.

“We are upbeat about the prospect of receiving regulatory approval from the U.S. FDA to launch sales of Herzuma and Truxima during the first six months of next year and plan to enter the U.S. market with Teva Pharmaceutical Industries, an exclusive distributor,” said Celltrion in a statement.

Celltrion, the No. 1 market capitalization stock on the secondary Kosdaq board, had its marketing subsidiary Celltrion Healthcare debut on the same bourse last Friday. The two companies took the first and second spots in terms of market capitalization on the Kosdaq Monday. Their combined market cap amounted to 19.8 trillion won, six times the market cap of Medytox, another pharmaceutical firm on the Kosdaq that ranks third by market cap.

BY SEO JI-EUN [seo.jieun@joongang.co.kr]