Roche reaches global settlement, licensing agreements with Mylan on Herceptin biosimilar

Mylan announced Monday that it agreed to the terms of a settlement with Roche and the Swiss drugmaker's Genentech unit in regards to patents for Herceptin (trastuzumab). Mylan indicated that following the settlement, as well as the FDA's recent acceptance of its biologics license application, it "anticipates potentially being the first company to launch a biosimilar to Herceptin in the US."

According to Mylan, the deal will give the company a "clear pathway" to commercialise its version of the breast cancer treatment in various global markets, adding that 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 stated. Specifically, the company said it has agreed to withdraw its pending legal challenge against two US Genentech patents as part of the deal. Other terms of the settlement and license agreement were not disclosed.

For further analysis on the adoption of biosimilar cancer treatments, see Biosimilars in Oncology: KOL Insight.

Mylan holds exclusive commercialisation rights for the proposed Herceptin biosimilar in the US, Canada, Japan, Australia, New Zealand and in Europe, while Biocon has co-exclusive marketing rights with Mylan for the product in the rest of the world. Mylan currently sells its version of the breast cancer treatment in 14 emerging markets, and that in addition to the US, there are submissions pending in the EU and several further emerging markets. The FDA is expected to render its decision on the Herceptin biosimilar filing by September 3.

Biocon and Mylan introduced the "world's first" biosimilar version of Herceptin in India in 2014 for the treatment of HER2-positive metastatic breast cancer. Last year, the Delhi High Court ruled that Biocon and Mylan could not market their product, sold under the names CANMAb, Bmab-200 and Hertraz, as a biosimilar of Herceptin, but it did not prevent them from selling the treatment. The companies presented data from the Phase III HERITAGE study at last year's ASCO conference, which they said showed that their proposed biosimilar was comparable to Herceptin. Earlier this month, the Delhi High Court passed an interim order permitting Mylan and Biocon to claim biosimilarity with Roche's product.