As we reported last November, the NOR-SWITCH Phase IV study concluded that patients could be safely and effectively switched from originator infliximab (Remicade®) to Celltrion’s biosimilar…
As we reported last November, the NOR-SWITCH Phase IV study concluded that patients could be safely and effectively switched from originator infliximab (Remicade®) to Celltrion’s biosimilar…
Below is our midwinter update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or…
As we previously reported, a jury trial in the ongoing infliximab biosimilar litigation, Janssen v. Celltrion (D. Mass., J. Wolf), was scheduled to begin on February 13, 2017. The district…
As we previously reported, in Janssen v. Celltrion, Janssen appealed the district court’s partial final judgment that Janssen’s ‘471 patent, directed to monoclonal antibodies…
With the pre-trial conference set to begin on February 6, 2017, the parties in Janssen v. Celltrion have filed several motions seeking to exclude or limit certain evidence and testimony…
Yesterday, in the Janssen v. Celltrion action, Janssen filed a supplemental brief on the issue of whether Hospira may be liable for infringement on the theories of joint enterprise, agency,…
After another milestone year, here are our picks for the top-five biggest deals in the world of biosimilars in 2016: 1) As we reported in January 2016, Mylan N.V. and…
Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2016: The FDA approved three biosimilar products in 2016, compared to only…
This morning, in the district court action in Janssen v. Celltrion, Judge Wolf issued an oral order denying the defendants’ motion for partial summary judgment of non-infringement of U.S. Patent…
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization to Celltrion’s Truxima (rituximab), a biosimilar…