Industry Trend Analysis - Trastuzumab Agreement A Defining Moment In Biosimilar Market Evolution - MAY 2017


BMI View: This settlement agreement represents a coming of age for the biosimilar market; whilst such agreements are common for simpler generics, this is the first time a major deal has been struck for a biosimilar. Roche has long cautioned over definitions of biosimilars, and has previously argued that Mylan and Biocon's trastuzumab is not biosimilar. The generic firms have needed to provide additional test data to show bioequivalence of a standard acceptable in regulated markets; this has been achieved and has evidently been recognised by Roche.

Genentech and its parent company, Roche, have entered into a global settlement agreement with Mylan in relation to patents for trastuzumab, marketed by Roche as Herceptin and used in treating various cancers. The agreement provides Mylan with global licences for its biosimilar trastuzumab.

The global licences, effective dates for commencement of which remain confidential, will provide a clear pathway for Mylan to commercialise its biosimilar in various markets across the world. The licences pertain to all countries except Japan, Brazil and Mexico. Mylan commented that in addition to eliminating any legal uncertainty over the launch of its biosimilar trastuzumab, the settlement also eliminates further patent litigation expenses associated with Genentech and Roche.

Herceptin Remains Important For Roche
Global Herceptin Sales (CHFmn)
Source: Roche, BMI

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