UPDATE : Sunday, February 23, 2020
Celltrion applies for FDA approval of new anticancer biosimilar
  • By Constance Williams
  • Published 2017.07.31 15:04
  • Updated 2017.07.31 16:46
  • comments 0

Celltrion Healthcare is preparing to release its third biosimilar Herzuma in the U.S. market, following Remsima and Truxima, the company said Monday.

Herzuma is an anticancer, antibody biosimilar used for the treatment of breast cancer and stomach cancer. Its originator drug Herceptin was developed by the U.S. biotechnology corporation Genentech and is sold by Roche.

Herceptin is a global blockbuster drug that generates annual sales of 7.9 trillion won ($7.0 billion), and U.S. sales of 3.48 trillion won in 2016.

Celltrion셀트리온 submitted Herzuma’s biologics license application (BLA) to the U.S. Food and Drug Administration in May, and the FDA accepted the request on the 60-day filing notification letter and will notify the approval until the first half of next year.

In January 2014, the Ministry of Food and Drug Safety approved Herzuma for the treatment of metastatic breast cancer and gastric cancer. To enhance their market competitiveness, the company applied for a marketing authorization to the European Medicines Agency (EMA) in October 2016 after completing a large-scale global clinical trial for early breast cancer patients.

Celltrion won the approval of FDA for its first anti-cancer antibody biosimilar Remsima in April 2016 and has applied for similar licensing for Truxima and Herzuma, expecting all of its first-mover antibody biosimilar products to be approved for marketing by the FDA.

In June, Celltrion announced the results of Phase 3 clinical trials of Herzuma’s early-stage breast cancer (EBC) drug at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, U.S., to demonstrate equivalence in efficacy and safety to the original drug.

"Herzuma proved its safety and efficacy equivalent to the original product based on its abundant clinical data and secure clinical trials compared to competitive products by publishing clinical papers in Lancet,” said Celltrion CEO Kee Woo-sung기우성. “Because there is a period left before the approval and release of the license, we will do our best to provide benefits to more patients in the U.S.”

Paul Rittman, vice president of anticancer drugs at Teva, an Israeli pharmaceutical company responsible for the distribution of Herzuma, also expressed his wishes. "We hope to quickly offer Celltrion's Herzuma to U.S. patients through a network of Teva that has strengths in anticancer drugs.”

“We will not hesitate to cooperate with Celltrion to open up the market of biocides with same efficacy and lower cost through early launch after approval of U.S. sales,” he added.


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