Celltrion biosim, eyeing Herceptin's megasales, measures up to the Roche med in phase 3

Celltrion reported that its biosim to Roche's Herceptin was shown to be similar in efficacy and safety to the reference med in a phase 3 trial.

Chasing biosim partners Mylan and Biocon for one of the top sales targets in the pharma industry, Celltrion reported Sunday that its version of Roche’s breast cancer med Herceptin stacked up to the reference blockbuster in a late-stage trial.

In a head-to-head test against Herceptin, Celltrion’s CT-P6 turned in similar safety and efficacy to the Roche med as a presurgery treatment for HER2-positive early breast cancer.


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Celltrion’s biosim measured up against the reference product in both the primary endpoint of pathological complete response—46.8% for CT-P6 and 50.4% for Herceptin—and secondary endpoints of overall response rate, pharmacokinetics, pharmacodynamics and safety.

RELATED: Roche's Herceptin one step closer to biosim battle with Mylan licensing deal

After surgery, patients received either the Celltrion biosim or Herceptin to complete a year of treatment, according to a release.

The company announced its results at the annual meeting of the American Society of Clinical Oncology. Further results will be published in The Lancet Oncology, according to the biosim developer.

Back in October, Celltrion sold U.S. and Canadian marketing rights to its Herceptin biosim, plus another for Roche’s Rixutan, to Israel’s Teva Pharmaceutical Industries for $160 million. The companies will share profits through the arrangement.

RELATED: Teva ponies up $160M-plus for marketing rights to Celltrion's Rituxan, Herceptin biosims

In their quest to bring a Herceptin biosim to the U.S. market, Celltrion and Teva trail partners Mylan and Biocon, which have submitted their biosim to the FDA and are awaiting a Sept. 3 action date. Those partners recently settled a patent dispute with Roche, clearing another hurdle in the way of their potential launch.

For its part, Celltrion has already applied for approval with its Herceptin biosim in Europe and Japan

A leading biosimilar developer globally, the South Korean company created Remsima, the biosim to Johnson & Johnson’s Remicade that quickly stole share in Europe. In the U.S., the company has partnered with Pfizer’s Hospira for that product, which launched last October. Another Celltrion biosim, to Roche’s Rituxan, won European approval back in February.

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