FDA rejects Pfizer’s Herceptin biosimilar

April 23, 2018

Pfizer announced this week that the FDA has declined to approve a new medication the company plans to sell as a lower-cost version of Roche’s cancer drug, Herceptin.

The company reported that the agency has requested “additional technical information,” and that it is unrelated to safety or clinical data.

Herceptin, which is used to treat cancer in the breast or of the stomach and gastroesophageal junction, generated $7.18 billion in sales last year. In December, the FDA approved Mylan and Biocon’s Herceptin biosimilar, Ogivri.

Pfizer said it is working with the agency to resolve issues with its biosimilar application. 

Read the full Reuters report.