Article

FDA to Evaluate Herceptin Biosimilar

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

This week, 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.

Related Videos
Anthony Perissinotti, PharmD, BCOP, discusses unmet needs and trends in managing chronic lymphocytic leukemia (CLL), with an emphasis on the pivotal role pharmacists play in supporting medication adherence and treatment decisions.
Image Credit: © alenamozhjer - stock.adobe.com
pharmacogenetics testing, adverse drug events, personalized medicine, FDA collaboration, USP partnership, health equity, clinical decision support, laboratory challenges, study design, education, precision medicine, stakeholder perspectives, public comment, Texas Medical Center, DNA double helix
pharmacogenetics challenges, inter-organizational collaboration, dpyd genotype, NCCN guidelines, meta census platform, evidence submission, consensus statements, clinical implementation, pharmacotherapy improvement, collaborative research, pharmacist role, pharmacokinetics focus, clinical topics, genotype-guided therapy, critical thought
Image Credit: © Andrey Popov - stock.adobe.com
Image Credit: © peopleimages.com - stock.adobe.com
TRUST-I and TRUST-II Trials Show Promising Results for Taletrectinib in ROS1+ NSCLC
Image Credit: © Krakenimages.com - stock.adobe.com
Image Credit: © Cavan - stock.adobe.com