Covers global markets with the exception of Japan, Brazil and Mexico
After months of wrangling in the courts, Mylan and Roche have agreed a licensing deal that should allow a biosimilar version of breast cancer drug Herceptin to reach the market.
Mylan said the settlement will "provide a clear pathway" for sales of its biosimilar copy of HER2-targeting Herceptin (trastuzumab) – which had revenues of $6.73bn last year – in all markets around the world except Japan, Brazil and Mexico.
The FDA has already accepted Mylan's Biologics Licensing Application (BLA) for its biosimilar trastuzumab and a verdict is due from the agency by September 3, so the company "anticipates potentially being the first company to launch a biosimilar to Herceptin in the US". The biosimilar has not yet been filed in Europe.
Mylan's biosimilar development partner Biocon has co-marketing rights in some markets outside North America, Europe, Japan and Oceania, and the two companies have already launched their copycat Herceptin in 14 emerging markets, including India.
Roche has always asserted that its patent estate for Herceptin was not due to expire in the US until 2019, but the settlement will save both companies the not-inconsiderable expense of fighting their patent infringement battle, although there are other biosimilar Herceptin developers waiting in the wings, including Amgen/Allergan, Pfizer, and Samsung Bioepsis. Financial details of the Mylan settlement have not been disclosed.
The emergence of biosimilars is expected to be challenging for Roche, which derives so much of its revenues from antibody drugs that have now started to lose patent protection. Aside from Herceptin, and biosimilars of Roche's Avastin (bevacizumab) and Rituxan/MabThera (rituximab) are also starting to reach the market.
Despite the competition, EvaluatePharma has suggested that Roche's blockbuster products will still be bringing in good revenues for the foreseeable future, as biosimilars do not tend to cause the steep declines on brands as traditional generics.
A recent forecast suggested Herceptin will be particularly resilient, still near-$4bn product in 2022, helped by combination use with Roche's newer HER2 drug Perjeta (pertuzumab) which grew 26% to more than $1.8bn last year.