Review of Herceptin biosimilars in the drug pipeline
Herceptin® (trastuzumab) is a recombinant monoclonal antibody used for the treatment of breast cancer and gastric cancer in combination with other chemotherapy agents. In 2017, it gained $2,804 million in sales in the United States, which has made it a target for the development of biosimilars.
Currently, there is one approved biosimilar called OGIVRI™ (trastuzumab-dkst) on the market, developed by Mylan in conjunction with Biocon. Three additional trastuzumab biosimilars are being developed by Amgen/Allergan, Celltrion/Teva, and Pfizer. All three have shown efficacy similar to the reference product Herceptin® in Phase III trials, and are currently in the Pre-Registration phase of development with expected PDUFA dates in April and May of 2018.
For our complete review of trastuzumab biosimilar pipeline:
Executive Summary of Evaluation:
|Status||Marketed||Approved||Submitted for Approval||Submitted for Approval||Submitted for Approval|
|Indications||Metastatic Breast Cancer||Approved||Approved||Submitted for Approval|
|Breast Cancer||Approved||Approved||Submitted for Approval||Submitted for Approval|
|Gastric Cancer||Approved||Approved||Submitted for Approval||Submitted for Approval|
|Interchangeable||Metastatic Breast Cancer||No|
|Efficacy||Metastatic Breast Cancer||Similar to Herceptin®||Similar to Herceptin®||Results Not Reported||Not Studied|
|Breast Cancer||Similar to Herceptin®||Similar to Herceptin®||Similar to Herceptin®||Results Not Reported|
|Gastric Cancer||Not Studied||Not Studied||Not Studied||Not Studied|
“Cancer Stat Facts: Female Breast Cancer.” National Cancer Institute: Surveillance, Epidemiology, and End Results Program, https://seer.cancer.gov/statfacts/html/breast.html. Accessed: February 26, 2018.
“Cancer Stat Facts: Stomach Cancer.” National Cancer Institute: Surveillance, Epidemiology, and End Results Program, https://seer.cancer.gov/statfacts/html/stomach.html . Accessed: February 26, 2018.
NIH U.S. National Library of Medicine ClinicalTrails.gov https://clinicaltrials.gov/ct2/home Accessed: February 25, 2018.
“FDA Approves First Biosimilar for the Treatment of Certain Breast and Stomach Cancers.” U.S. Food and Drug Administration, 1 Dec. 2017, www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587378.htm. Accessed February 21, 2018.
Global Data Pharma Intelligence Center https://pharma.globaldata.com Accessed: February 23, 2018.
RJ Health Reimbursement Codes https://rc2.reimbursementcodes.com Accessed: February 23, 2018.
Coauthored by: Kristen Ciampi, PharmD Candidate
Kristen is a sixth-year pharmacy student at the University of Rhode Island. Kristen is completing her studies through an advanced pharmacy practice rotation at RJ Health prior to graduating with a PharmD degree in May of 2018.
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