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Celltrion’s biosimilar on way to U.S. market

Oct 12,2018
Celltrion said Thursday that an advisory committee for the U.S. Food and Drug Administration (FDA) recommended the approval of its biosimilar Truxima to treat certain kinds of cancer.

An official approval by the U.S. health authority could come as early as December, because it usually takes between two and three months after the panel’s recommendation.

Truxima is used in the treatment of a number of diseases, including rheumatoid arthritis and non-Hodgkin’s lymphoma, a type of leukemia.

In a meeting on Wednesday, the 16 members of the Oncologic Drugs Advisory Committee (ODAC) of the U.S. FDA voted unanimously for Truxima to be approved for use in the United States.

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.

The biosimilar referenced MabThera/Rituxan, originally developed by Swiss pharmaceutical giant Roche. The original drug sells under the brand name MabThera in Europe and Korea, and Rituxan in the United States.

“CT-P 10 [a code name for Truxima] is highly similar to U.S.-Rituxan, notwithstanding minor differences in clinically inactive components, and there are no clinically meaningful differences between CT-P10 and U.S.-Rituxan in terms of the safety, purity and potency of the product,” said the committee in the briefing document.

“We welcome the ODAC’s recommendation. If taken up by the FDA, Truxima will be the first Rituxan biosimilar to be approved in the United States for the proposed uses,” the company’s CEO Kee Woo-sung said in a release. “The development of biosimilars is of great importance in the field of oncology, and has the potential to increase accessibility to treatments for the patients.”

Truxima has been under FDA review since June, following a resubmission of its application for marketing approval in May, after its first attempt failed due to production facility and manufacturing process issues. In the United States, Truxima is set to become the first biosimiar for Rituxan.

The FDA holds public advisory committee meetings before it makes decisions. The ODAC reviews and evaluates the safety and effectiveness of investigational human drug products for use in the treatment of cancer.

The recommendation from the ODAC comes four months after Truxima became available for purchase in 18 European countries. The U.S. government has recently been moving to encourage cheaper biosimilar products to slash medical product prices.

Europe’s approval prompted the United States to consider accepting the Korean drug, industry insiders say

MabThera/Rituxan faces competition from biosimilars both in Europe and in the United States. Roche said in a 2017 annual report that European sales of MabThera declined by 11 percent from a year earlier due to two biosimilars including Celltrion’s.

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


BY SEO JI-EUN, YONHAP [seo.jieun@jooongang.co.kr]


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