Herceptin® (Trastuzumab) Biosimilars – 2018 Drug Pipeline Review

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:

GET THE FULL REVIEW AT THE RESOURCE LIBRARY

Executive Summary of Evaluation:

    HERCEPTIN®

(Genentech)

OGIVRI

(Mylan/Biocon)

Trastuzumab Biosimilar

(Pfizer)

Trastuzumab Biosimilar

(Celltrion/Teva)

Trastuzumab Biosimilar

(Amgen/Allergan)

Regulatory

 

Status Marketed Approved Submitted for Approval Submitted for Approval Submitted for Approval
PDUFA 04/30/2018 04/30/2018 05/28/2018
   
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
  Breast Cancer No
  Gastric 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

References:

“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 Systems Reimbursement Codes https://rc2.reimbursementcodes.com Accessed: February 23, 2018.

Pipeline Update:
April 5, 2018 – Celltrion announced the FDA issued a complete response letter (CRL) for their trastuzumab biosimilar requesting additional information.  While these actions may delay the FDA approval date, the manufacturer still anticipates approval in 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 Systems prior to graduating with a PharmD degree in May of 2018.


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