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# FDA Rejects Pfizer Herceptin Biosimilar
- URL: https://www.fdaweb.com/fda-rejects-pfizer-herceptin-biosimilar/
- Published: 2018-04-23T12:00:00.000Z
- Updated: 2026-09-15T00:00:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141281

FDA has sent Pfizer a complete response letter on its BLA for the company’s proposed trastuzumab biosimilar, a copy of Genentech’s Herceptin, indicated for treating patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors over-express the HER2 gene. In the letter, the agency highlighted the need for additional technical information, according to the company. The additional requested information does not relate to safety or clinical data in the submission, it says.