Mylan settles cancer drug patent dispute with Genentech

Mylan has entered a settlement with Genentech and its parent company, Roche, in relation to patents for cancer drug Herceptin (trastuzumab).

According to a  statement released yesterday, March 14, Mylan now has a global licence for its biosimilar product.

The licence will allow Mylan to commercialise its product around the world apart from in Japan, Brazil and Mexico.

As part of the settlement, Mylan has agreed to withdraw its pending inter partes review challenges against Genentech concerning US patent numbers 6,407,213 and 6,331,415.

Mylan said that it expects to be potentially the first company to launch a Herceptin biosimilar in the US.

Heather Bresch, CEO of Mylan, said: "There is an unmet need for access to more affordable versions of biologic products such as trastuzumab.”

She added that with 16 biosimilar products in development, Mylan has one of the industry's broadest portfolios of biosimilars.

Mylan currently has exclusive commercialisation rights for the proposed biosimilar trastuzumab in the US, Canada, Japan, Australia, New Zealand, the EU and European Free Trade Association.

Biocon, an India-based biopharmaceutical company, has co-exclusive commercialisation rights with Mylan for the product in the rest of the world.

Mylan's Biologics License Application for the proposed biosimilar of trastuzumab is currently being reviewed by the US Food and Drug Administration.