The FDA has only approved eight biosimilar products to date. The second most recently approved biosimilar is Mvasi (bevacizumab-awwb), which is manufactured by Amgen and was approved as a biosimilar to Genentech’s Avastin (bevacizumab) on September 14, 2017.
On October 6, 2017—about three weeks after the FDA approved Mvasi—Amgen provided Genentech with a notice of commercial marketing and filed a declaratory suit in the U.S. District Court for the Central District of California of non-infringement and invalidity of Avastin-related patents. Genentech, on the other hand, filed a suit involving the Avastin patents in the U.S. District Court for the District of Delaware on that same day (or “[s]hortly after midnight, on October 7, 2017” according to a filing by Amgen in the case) and then another such suit on October 18, 2017. Currently pending in both Delaware cases are motions by Amgen to transfer to the Central District of California and to dismiss Genentech’s complaints for failure to state a claim. Meanwhile, in the Central District of California, Genentech has filed a motion to dismiss for lack of jurisdiction, which is still pending an order.
Mvasi is significant because it is the first biosimilar approved in the United States for the treatment of cancer. The second U.S. biosimilar approved for the treatment of cancer is the most recently approved biosimilar: Ogivri (trastuzumab-dkst). Co-developed by Mylan and Biocon, Ogivri is a biosimilar to Genentech’s Herceptin (trastuzumab). Ogivri is the first U.S. biosimilar approved for treatment of breast cancer or stomach cancer. The FDA announced approval of Ogivri on December 1, 2017.
Unlike with Mvasi, no litigation is likely to follow this approval of Ogivri because Mylan, Genentech, and Genentech’s parent (Roche) previously agreed to a global settlement and license agreement related to the Herceptin patents. This arrangement was announced in March 2017 and is mostly confidential, though it did involve Mylan withdrawing inter partes review challenges against two of Genentech’s patents. Also, Mylan’s announcement of the settlement and license agreement stated that the “global license will provide a clear pathway for Mylan to commercialize its trastuzumab product” and that “[i]n 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.”
Biosimilar manufacturers have many decisions to make regarding how to proceed under the Biologics Price Competition and Innovation Act (BPCIA) and the “patent dance” it prescribes. As demonstrated by Mvasi though, one option is to avoid the costs, risks, and uncertainties of litigation by negotiating license agreements. Of course, circumstances surrounding such agreements can always change, which Mylan recognized when it qualified the above statements about its own settlement and license agreement as “forward-looking statements” that “inherently involve risks and uncertainties.”