FDA approves Pfizer’s Herceptin biosimilar Trazimera

pharmafile | March 12, 2019 | News story | Manufacturing and Production, Sales and Marketing Humira, Pfizer, Trazimera, biosimilar, pharma 

Patients in the US will now be able to access another biosimilar version of Herceptin (trastuzumab) with the FDA approval of Pfizer’s Trazimera in the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Data supplied with the application supported the similarity of Trazimera to its reference product, including clinical equivalence and no clinically meaningful differences between them.

This latest approval marks the fifth for a Pfizer biosimilar from the FDA, and the first such approval within the field of oncology. The drug was also approved in the EU for the same indications in July 2018.

“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,” remarked Dr Mark Pegram, Associate Director for Clinical Research at the Stanford Comprehensive Cancer Institute, and Director of the Breast Oncology Program at the Stanford Women’s Cancer Center. “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.”

“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,” commented Andy Schmeltz, Global President at Pfizer Oncology. “We are proud to be able to offer treatment options that can help address the diverse needs of patients.”

Matt Fellows

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