April 27, 2024

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[THE INVESTOR] Celltrion said on July 31 that the US Food and Drug Administration has accepted the firm’s license application for Herzuma, its biosimilar copy of Roche’s blockbuster breast cancer treatment Herceptin.

The company said the US drug regulator’s final approval is expected to come in the first half of next year. 

After launching its first biosimilar Remsima, the copycat version of Johnson and Johnson’s Remicade, in the US in November last year, Celltrion is now preparing for the US debut of two more biosimilar drugs. Along with Herzuma, Truxima, its biosimilar version of Roche’s Rituxan, is also awaiting FDA approval.

The company claimed US sales of the three original drugs stand at about 8 trillion won (US$7.13 billion).

“Herzuma proved its safety and efficacy equivalent to the original drug through abundant clinical data. We will do our best to provide industry-leading treatment benefits to more patients in the US,” Celltrion CEO Kim Sung-woo said in a press release. The drug maker plans to sell Herzuma via its retail partner Teva in the US.

Herzuma also filed for approval in the EU in October last year and in Japan in April.

By bringing Remsima, the world’s first monoclonal antibody biosimilar approved in the US and EU, Celltrion has made a name for itself in the global biosimilar market. According to IMS Health, Remsima stole 42 percent market share of the original Remicade in Europe.

But competition for the Herceptin biosimilar seems to be fiercer with many global biotech firms lining up to enter the lucrative market. Leading the pack is Mylan and Biocon whose Herceptin biosimilar was recommended fFDA approval on July 13. Celltrion’s local rival Samsung Bioepis has also submitted its own version for approval in the EU, while Allergan and Amgen’s copy is under review by the EMA.

Roche, the original maker, is also taking action to defend its market share from copycat rivals, including launching a new subcutaneous formula that it believes will offer more convenience to patients and extend the original drug’s life span.

By Park Han-na (hnpark@heraldcorp.com)