Table of Contents
I. Introduction
II. FDA Commissioner’s Statement
III. Mylan and Biocon Collaboration
• Overview of the six biologic products developed
• Comparison of Ogivri to Roche’s Herceptin
IV. Breast Cancer Statistics and Symptoms
• Number of breast cancer survivors in the US
• Common symptoms of breast cancer
V. Stomach Cancer Statistics
• Incidence of stomach cancer in the US
• Annual death rate for stomach cancer
VI. Conclusion
US FDA approved Ogivri co-developed by Mylan and Biocon for the treatment of breast and stomach cancer. The drug is the first biosimilar approved in the United States for treating cancer of stomach and breast, and second biosimilar overall approved for therapeutic use in oncology. A biosimilar is no different than a biologic drug as it is comparable to the reference product in terms of safety, purity, and potency.
According to FDA Commissioner Scott Gottlieb, “The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs. This is especially important when it comes to diseases like cancer, that have a high-cost burden for patients.” He also added, “We’re committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs.”
In total, Mylan and Biocon have codeveloped six biologic products through collaboration. The latest product is comparable to Roche’s biologic drug Herceptin, a blockbuster drug used in treating stomach or breast cancer. Biologic drugs are made from living cells and are understood to be hard to reverse engineer for commercial exploitation by competitors. Similar versions are called biosimilars instead of generics.
There are 3.1 million breast cancer survivors in the United States and chances of dying from breast cancer is one in 37. The symptoms of breast cancer include pain in the armpits, redness of the skin, rash around one or both nipples, a discharge from a nipple, change in size of the breast and peeling of the skin on the breast. Nearly 20,000 cases of stomach cancer are diagnosed every year in the United States and approximately 10,000 people die of stomach cancer annually.