Mylan’s pathway to launch of biosimilar to Herceptin cleared by Roche
Mylan scored a big victory in its plan to launch its biosimilar to Roche’s blockbuster, Herceptin, after Roche and itself agreed a global licensing pact. The agreement comes shortly after Mylan won a victory in India to launch its biosimilar there, and not long after Roche received positive results for its Herceptin-Perjeta combination treatment.
The agreement between the two companies means that Mylan is looking increasingly likely to be the first company to reach the market with its biosimilar to Herceptin. The market is an incredibly valuable one, with Roche’s drug bringing in $6.7 billion last year alone.
Roche had fought the move to bring Mylan’s biosimilar to the Indian market since 2014 and had managed to stall its emergence in worldwide markets up until this point. Roche’s efforts have paid off as it received positive results on its combination of Herceptin and Perjeta in early stage breast cancer, giving it an advantage over any biosimilar that enters the market.
The settlement between the two companies has resulted in Mylan agreeing to withdraw its pending Inter Partes Review challenge against two of Genentech’s (a subsidiary of Roche) patents. In return, Mylan has a global license, barring Japan, Brazil and Mexico, to commercialise its biosimilar. Though the particular dates for when this process will begin have not yet been released; Roche have previously stated that it does not expect a biosimilar to reach the US market until the autumn of this year.
Mylan CEO Heather Bresch commented, "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. With 16 biosimilar products in development, we believe Mylan has one of the industry's broadest portfolios of biosimilars and that we will be a leader in bringing high-quality biosimilar products to market given our ability not only to develop and manufacture such complex products, but also to navigate the intricate regulatory and legal environment and successfully commercialize these products on a global basis."
- Mylan’s breast cancer biosimilar matches Roche’s Herceptin in Phase III trial
- EMA accepts regulatory submission for proposed Herceptin biosimilar
- Phase III study confirms similarity of Herceptin biosimilar from Amgen, Allergan
- India court grants Herceptin injunction
- Roche abandons Herceptin patents in India