FDA Accepts Trastuzumab Biosimilar for Review

Trastuzumab (Herceptin) is indicated to treat HER2+ breast and gastric cancers.

Today, Samsung Bioepis announced that the FDA accepted for review a biologics license application for SB3, a biosimilar of trastuzumab (Herceptin), according to a press release.

This drug is the first oncology biosimilar submitted to the FDA for approval.

Samsung Bioepis said that if approved, SB3 would be commercialized by Merck.

About trastuzumab (Herceptin)

Trastuzumab is a Genentech oncology biologic drug that is indicated for multiple types of cancer.

Currently, trastuzumab is approved for early stage HER2+ breast cancer that has or has not spread to the lymph nodes. It is also approved to treat patients with metastatic HER2+ breast cancer.

Trastuzumab is approved as a combination therapy for treatment-naïve patients with HER2+ metastatic stomach or gastroesophageal junction cancer.

The most common side effects associated with trastuzumab are fever, nausea, vomiting, infusion reactions, diarrhea, infections, cough, headache, feeling tired, shortness of breath, rash, low white and red blood cell counts, and muscle pain, according to Genentech.