Pfizer’s Herceptin Biosimilar gets FDA Approval as US Entry Nears

Andrew Dunn, Biopharma Dive

March 12, 2019

Dive Brief:

The Food and Drug Administration has approved a fourth biosimilar of Roche’s top-selling cancer therapy, Herceptin.

Pfizer said Monday its Herceptin copy, which will be sold under the name Trazimera, secured the FDA’s OK, overcoming a Complete Response Letter issued last April that requested additional technical information. Trazimera gained European approval in July 2018.

The FDA has approved Herceptin biosimilars from Mylan and Biocon, Samsung Bioepis, and Teva and Celltrion. None, however, are commercially available yet.


Dive Insight:

More than 20 years after Herceptin (trastuzumab) first gained FDA approval, lower-cost copycat competition is nearing.

While Roche began facing biosimilar competition to the drug in Europe and Japan last year, the Swiss pharma anticipates U.S. entry of Herceptin copies in the second half of 2019.

Pfizer’s approval makes it the third Herceptin biosimilar approved by the FDA in the last four months, suggesting the potential for quick entry of multiple competitors later this year. Herceptin was Roche’s top-selling drug in 2018, posting sales of 6.98 billion Swiss francs ($6.93 billion) last year. About 40% of those sales were from the U.S. market.

Those sales numbers are expected to sizably drop in 2019. The European and Japanese markets both saw sales fall 16% last year for the commonly used breast cancer therapy.

Roche already faced competition to another of its blockbuster cancer therapies, Rituxan (rituximab). Combined with Herceptin, biosimilar erosion ate away roughly $1.2 billion from Roche’s total 2018 sales. While Rituxan took a bigger hit last year, the pharma expects Herceptin to see the larger sales dip in 2019, Bill Anderson, the CEO of Roche Pharmaceuticals said earlier this year.

“In 2019, that will probably kind of reverse itself, as most of the damage has already happened on MabThera, and Herceptin will be more affected,” Anderson said during Roche’s fourth quarter earnings presentation, using Rituxan’s branded name in Europe.

But Roche has a plan for extending Herceptin’s profitable run. Just a couple weeks ago, the FDA approved a subcutaneous version of the cancer therapy, which has already been available in Europe for a number of years. That offering could help Roche sustain sales of its Herceptin offering even amid biosimilar competition.

Subcutaneous Herceptin is also being tested in combination with Roche’s drug Perjeta (pertuzumab), with a submission for approval targeted for 2020.

For Pfizer, Trazimera (trastuzumab-gyyp) is the big pharma’s fifth FDA-approved biosimilar, which makes Pfizer the industry’s leader for the number of U.S.-approved biosimilars, according to the agency’s list of such products.


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