[News Focus] Celltrion to accelerate US entry on imminent FDA approval

So Jae-hyeon  Published 2018.10.12  15:40  Updated 2018.10.12 15:40


Cellrion is expected to accelerate its move to enter the U.S. market with an imminent approval for an anticancer biosimilar from the U.S. drug regulator.

The South Korean drugmaker said on Thursday that the U.S. Oncologic Drugs Advisory Committee (ODAC) recommended the biosimilar Truxima (rituximab), or CT-P10, for approval of the Food and Drug Administration.

Truxima, a copy of Roche’s Rituxan, treats patients with non-Hodgkin’s lymphoma.

ODAC is an independent advisory body that provides FDA with comprehensive opinions on the quality, safety, and economics of medicines under consideration. The committee’s decision is an essential reference point for the FDA's decision to approve a drug.

The ODAC said Truxima and the original drug were highly similar in terms of biological equivalence and safety, based on credible clinical data.

Celltrion welcomed the ODAC’s decision, saying would raise its chance to win approval for Truxima in the U.S. Generally, it takes about two or three months to obtain an official FDA nod after the ODAC’s recommendation for approval.

Effect of Celltrion’s becoming first biosimilar supplier in US?

The U.S. market for rituximab is estimated to be 5 trillion won ($4.4 billion) a year and 56 percent of the global sales of rituximab come from the U.S.

Such a tremendous size of the market is driving many pharmaceutical firms to develop rituximab biosimilars.

Observers said Celltrion is likely to lead the rituximab biosimilar market in the U.S.

Celltrion introduced Remsima (Inflectra in the U.S), the world’s first biosimilar product, to the U.S.

In April last year, Celltrion submitted to the FDA data needed for Truxima approval for all indications of rituximab including non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis. After a 60-day review, the company applied for approval in June.

If Celltrion receives the green light for Truxima from the FDA, it will be the first seller of Rituxan biosimilar in the U.S. The company had chosen Teva Pharmaceutical as the sales partner.

While Sandoz and Pfizer are rushing to get their rituximab biosimilars approved, Celltrion plans to secure a larger market share as the first supplier.

Celltrion has experienced an encouraging sales growth of Truxima in Europe already.

According to a report by Celltrion Healthcare, the owner of the Celltrion’s biosimilar global sales rights, 35 percent of Celltrion’s 312.1 billion won sales in the first half came from Truxima sales. Truxima is estimated to have sold more than 100 billion won in the first half.

In Europe, Truxima took up 27 percent of the market share. Its share was particularly high at 66 percent in the Netherlands, and 56 percent in the U.K.

Although biosimilars are not as popular in the U.S. as in Europe, the U.S. policy to support biosimilars to cut medical costs is good news to Celltrion.

“We welcome the positive opinion of the ODAC for Truxima approval. We are proud to become the first company to make Truxima become the first rituximab biosimilar in the U.S. to receive FDA approval recommendation,” said Celltrion CEO Kee Woo-sung.

“We will do our best to improve the quality of patients’ lives by providing biosimilar treatments that have equivalent efficacy with original drugs.”

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