On December 1, 2017, the United States Food and Drug Administration (USFDA) gave approval to Ogivri (trastuzumab-dkst), as a Biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer whose tumors overexpress the HER2 gene (HER2+). Ogivri, approved as a Biosimilar and not as an interchangeable product, is the first Biosimilar approved in the United States for the treatment of breast cancer or stomach cancer, and on the second Biosimilar approved in the United States for the treatment of cancer.
The FDA defines Biosimilar as a biological product that is 'highly similar' to and has 'no clinically meaningful differences' from an existing FDA-approved reference product1. Amanufacturer developinga proposed biosimilar demonstrates that its product is highly similar to the reference product by extensively analyzing (i.e., characterizing) the structure and function of both the reference product and the proposed biosimilar. State-of-the-art technology is used to compare characteristics of the products, such as purity, chemical identity, and bioactivity. The manufacturer uses results from these comparative tests, along with other information, to demonstrate that the biosimilar is highly similar to the reference product. The manufacturer must also demonstrate that its proposed biosimilar product has no clinically meaningful differences from the reference product in terms of safety, purity, and potency (safety and effectiveness). This is generally demonstrated through human pharmacokinetic (exposure) and pharmacodynamic (response) studies, an assessment of clinical immunogenicity, and, if needed, additional clinical studies.
The approval of Ogivri is based on the review of evidence that included data from extensive structural and functional characterization, animal study, human pharmacokinetic and pharmacodynamic, clinical immunogenicity and other clinical safety and effectiveness that demonstrates Ogivri is Biosimilar to Herceptin2. The USFDA granted approval of Ogivri to Mylan GmbH, the first biosimilar from Mylan and Biocon´s joint portfolio approved in the United States. Mylan anticipates potentially being the first company to offer a biosimilar to Herceptin. Mylan and Biocon's biosimilar for Herceptin is also under review by regulatory authorities in Australia, Canada, Europe and several additional markets. It is already approved in 19 countries around the world, including India, thus providing increased access to this more affordable biologic for cancer patients.
About Ogivri (Trastuzumab)
Trastuzumab is a HER2/neu receptor antagonist indicated for the treatment of HER2 overexpressing breast cancer; HER2-overexpressing metastatic gastric or gastro-esophageal junction adenocarcinoma and metastatic stomach cancer3,4.
About HER2 overexpression
The HER2 (human epidermal growth factor receptor 2) is a gene that plays a role in the development of breast cancer. HER2 gene makes HER2 proteins. HER2 proteins are receptors on breast cells. Normally, HER2 receptors help control how a healthy breast cell grows, divides, and repairs itself. But in about 25% of breast cancers, the HER2 gene doesn't work properly and makes too many copies of itself (known as HER2 gene amplification). All these extra HER2 genes propel breast cells to produce too many HER2 receptors (HER2 protein overexpression), making breast cells grow and divide uncontrollably5.
Note -
Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. Biosimilar for Herceptin is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace.
Footnotes
2 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587378.htm
3 https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103792s5250lbl.pdf
5 http://www.breastcancer.org/symptoms/diagnosis/her2
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