Pfizer’s biosimilar to Roche’s Herceptin receives approval from FDA

Pfizer has secured approval from the US Food and Drug Administration (FDA) for its drug Trazimera (trastuzumab-qyyp), a biosimilar medicine to Roche’s Herceptin (trastuzumab).

The approval covers indication for human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Trazimera binds to the HER2 protein and blocks the receptors, thereby halting cell division and growth. Meanwhile, Herceptin is designed to target the protein which is present on the surface of certain cancer cells and can trigger the cells to divide and grow.

Their similar modes of operating mean they have an equivalent impact on patients.

The FDA decision comes after review of a comprehensive data set, which showed similarity between Pfizer’s biosimilar and Herceptin.

The data set included results from the REFLECTIONS B327-02 clinical comparative study published in the British Journal of Cancer. This study demonstrated clinical equivalence, with a high degree of similarity and no clinically meaningful differences between Trazimera and Herceptin in patients with first line HER2 overexpressing metastatic breast cancer.

"Approximately 15%-30% of breast cancers and 10%-30% of gastric cancers are HER2-positive, which is associated with aggressive disease and poor prognoses for patients."

Stanford Comprehensive Cancer Institute associate director for clinical research Dr Mark Pegram said: "Approximately 15%-30% of breast cancers and 10%-30% of gastric cancers are HER2-positive, which is associated with aggressive disease and poor prognoses for patients.

"With the availability of biosimilars like Trazimera in the US, oncologists will have additional treatment options to choose from, which may help provide patients with greater access to the medicines they need."

The Trazimera FDA approval comes nearly a year after the regulatory authority sent a complete response letter to Pfizer’s biologics licence application and requested more technical information.

It is Pfizer’s first oncology biosimilar and the fifth FDA-approved biosimilar in the company’s portfolio.

In July 2018, the biosimilar secured the European Commission (EC) approval for the treatment of HER2 overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Pfizer Oncology global president Andy Schmeltz said: "This is an important milestone in the US, which both adds to our growing portfolio of oncology treatments and has the potential to improve access to cancer care."

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