FDA Approves 18th Biosimilar, 4th for Herceptin

Regulatory NewsRegulatory News | 12 March 2019 |  By 

The US Food and Drug Administration (FDA) late Monday approved the 18th biosimilar, Pfizer’s Trazimera (trastuzumab-qyyp), which is the fourth approved in the US for Roche’s Herceptin (trastuzumab).

Pfizer told Focus it’s working to make Trazimera available to patients as soon as possible but could not provide a specific launch date. The biosimilar is approved for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

None of the other three approved Herceptin biosimilars have launched in the US. Competitors include Merck and Samsung Bioepis’ Ontruzant (trastuzumab-dttb), approved in January; Celltrion’s Herzuma (trastuzumab-pkrb), approved in December 2018; and Mylan and Biocon’s Ogivri (trastuzumab-dkst), approved in December 2017.

Mylan, which settled with Roche, said in March 2017 that it anticipates it will be the first company to launch a biosimilar to Herceptin in the US.

In Europe, according to Bernstein Research, Herceptin biosimilars are now capturing 27% share of the reference product market after eight months of competition. There are also four competitors for Herceptin in Europe: Ontruzant, which launched last March; Herzuma, which launched last May; Amgen’s Kanjinti, which Bernstein said started showing up as promotional product in June in Germany; and Pfizer’s Trazimera, which was approved last July.

Austria has seen the highest adoption rate in Europe, with 79% biosimilars as volume share of the reference molecule in the eight months since launch.

Herceptin sales in 2018 totaled almost $7 billion worldwide for Roche. Herceptin sales fell by 16% overall in Europe in 2018 because of the biosimilar launches, the company said.


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