Mylan's Settlement With Genentech and Roche Opens US Market for Trastuzumab Biosimilar

Mylan has entered a global settlement with Genentech Inc and F. Hoffman-La Roche Ltd on a patent for trastuzumab (Herceptin), which will provide the company with global licenses for its trastuzumab biosimilar.

Under the global license, Mylan can now commercialize its product around the globe, except in Japan, Brazil, and Mexico. Today’s announcement ensures that the US market will see the first biosimilar to trastuzumab, once Mylan’s biologics license application—filed in collaboration with Biocon—is approved by the FDA. The Biosimilar User Fee Act for trastuzumab is September 3, 2017. The 2 companies have co-developed 5 other biologics.

“There is an unmet need for access to more affordable versions of biologic products such as trastuzumab. We look forward to enhancing access to this important treatment option, which complements our comprehensive cancer care offerings, in the U.S. and around the world,” said Heather Bresch, CEO of Mylan.

While Mylan has already been marketing the product in 14 emerging markets around the globe, the US and European markets would provide the most value—Roche reported sales of nearly $4.5 billion in 2016 alone. Just last week the New Delhi high court ruled in favor of Mylan being able to sell the trastuzumab biosimilar in India for additional indications using Roche’s package inserts for Herceptin.