Development of trastuzumab
The drug was first discovered by scientists including Dr. Axel Ullrich and Dr. H. Michael Shepard at UCLA’s Jonsson Comprehensive Cancer Center, Dr. Dennis Slamon subsequently worked on trastuzumab’s development. Genentech developed trastuzumab jointly with UCLA, beginning the first clinical trial with 15 women in 1992. By 1996, clinical trials had expanded to over 900 women, but due to pressure from advocates based on early success, Genentech worked with the FDA to begin a lottery system allowing 100 women each quarter access to the medication outside the trials. Herceptin was Fast-tracked by the FDA and gained approval in September 1998.
Trastuzumab, sold under the brand name Herceptin among others, is a monoclonal antibody used to treat breast cancer. Specifically it is used for breast cancer that is HER2 receptor positive. It may be used by itself or together with other chemotherapy medication. Trastuzumab is given by slow injection into a vein and injection just under the skin.
Biosimilar Development of Trastuzumab
Around 20 companies worldwide, particularly from emerging markets, are developing biosimilar versions of the drug ‘Herceptin’ after Roche/Genentech’s patents expired in 2014 in Europe, and in 2019 in the United States. In 2013, Roche/Genentech relinquished its patent right for the drug in India because of the difficult IP environment there. In the same year, the first biosimilar version of the drug, developed by Biocon and Mylan, received market authorization. In January 2015, BIOCAD announced the first trastuzumab biosimilar approved by the Ministry of Health of the Russian Federation. Iran also approved its own version of the monoclonal antibody in January 2016, and announced its readiness to export the drug to other countries in the Middle-East and Central Asia when trade sanctions were lifted.
11 Jan 2017, US FDA accepts BLA for Trastuzumab biosimilar for Breast cancer for review.
Patent Litigation case with Mylan and Settlement
Mylan N.V., a global pharmaceutical company, has agreed to the terms of a global settlement with Genentech, Inc. and F. Hoffmann-La Roche Ltd. in relation to patents for Herceptin (trastuzumab), which provides Mylan with global licenses for its trastuzumab product.
The global license will provide a clear pathway for Mylan to commercialize its trastuzumab product in various markets around the world, commencing on the license effective dates, which are confidential. The licenses pertain to all countries except Japan, Brazil and Mexico. In addition to eliminating any legal uncertainty over the launch of Mylan’s trastuzumab, the settlement eliminates further patent litigation expenses associated with Genentech and Roche.
Mylan has agreed to withdraw its pending Inter Partes Review (IPR) challenges against two US Genentech patents (patent numbers 6,407,213 and 6,331,415) as part of the settlement.
Following this settlement and the recent acceptance of Mylan’s application for its proposed biosimilar trastuzumab with the US Food and Drug Administration (FDA), Mylan anticipates potentially being the first company to launch a biosimilar to Herceptin in the US.
All other terms and conditions of the settlement and license agreement are confidential.
Mylan’s proposed biosimilar trastuzumab is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the proposed biosimilar trastuzumab in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.
In the U.S., Mylan’s Biologics License Application (BLA) for proposed biosimilar trastuzumab is currently under review by FDA. The anticipated FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Sept. 3, 2017.
Mylan currently markets its trastuzumab products in 14 emerging markets and has submissions pending in the European Union and several additional emerging markets, in addition to the U.S.