Mylan expects first US Herceptin biosimilar launch

Mylan expects to be the first to launch a cut-price biosimilar of Roche’s Herceptin (trastuzumab) breast cancer drug in the US, after reaching a “global settlement” with the Swiss company.

The generics firm said the “global licence” deal will clear the path for Mylan to market its Herceptin copycat on the confidential licence dates in all countries except, Japan, Brazil and Mexico.

Herceptin is one of Roche’s three biggest selling drugs – generating sales of almost $6.8 billion, and went off patent in Europe in 2014 and in 2018 or 2019 in the US.

As part of the agreement, it will withdraw its pending challenges against two patents held by Roche’s Genentech unit in the US.

The rest of the settlements are confidential, said Mylan, and in the complex world of US drug patents it’s difficult to predict a launch date – especially given that a forthcoming Supreme Court ruling may remove the six-month delay following approval under current arrangements.

But the wording of Mylan’s statement sparked speculation that it will be able to launch its biosimilar trastuzumab in the US if the FDA approves it on its target date of 3 September.


The biosimilar is one of six biologics developed in partnership with India’s Biocon. Mylan has exclusive marketing rights in the US, Canada, Europe, Japan, Australia and New Zealand, while Biocon has co-exclusive rights with Mylan for the product in the rest of the world.

Amgen and Allergan are also developing a biosimilar of Herceptin, reporting top-line phase 3 data last year showing that their near-copy is non-inferior to the originator, and may even be better.

South Korea’s Celltrion is also preparing a Herceptin biosimilar and last month launched a patent challenge against Roche in the US.

However Celltrion is playing catch-up with Mylan and is only in the early stages of developing its biosimilar Herceptin for the US market.

Roche is focusing on a newer generation of breast cancer drugs, earlier this month announcing late-stage study findings showing Perjeta (pertuzumab) improved survival in early breast cancer after surgery.

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