The High Court in London revoked two patents of Roche's mAb, Herceptin, potentially clearing a path for the introduction of a biosimilar version in the EU. Hospira (and its partner Celltrion) are expected to be the most immediae beneficiaries of the decision. Roche says nothing is imminent, but just look at wha happened earlier this year in India where both Biocon and Mylan rushed Herceptin versions to the market after a similar court ruling there.
Hospira and Celltrion already have a track record of getting a biosimilar version of Remicade approved in the EU last year. In addition to the Biocon and Mylan introductions of Herceptin copies in India, Celltrion also has introduced its version of Herceptin in South Korea.
In my view the flood gates are opening, and it is clear that biosimilars will be successfully introduced throughout the world -- and who knows? Maybe someday, there will even be biosimilars introduced in the good ol' USA. See Biopharm-reporter.
Posted by Bruce Lehr April 16th 2014.