As we previously reported in the dispute brought by Janssen against Hospira and Celltrion regarding infliximab, Defendants filed a motion to dismiss the 2015 and 2016 consolidated actions for lack…
As we previously reported in the dispute brought by Janssen against Hospira and Celltrion regarding infliximab, Defendants filed a motion to dismiss the 2015 and 2016 consolidated actions for lack…
Sandoz announced today that it has received approval for the use of Rixathon® in Europe. Rixathon® is a biosimilar version of Roche’s MabThera® (rituximab) and is approved for use in…
Celltrion Healthcare presented new data on their Rituximab biosimilar Truxima® (CT-P10) at the International Conference on Malignant Lymphoma (ICML) in Switzerland and the European League Against…
According to a May 7, 2017 record on ClinicalTrials.gov, Celltrion is conducting a Phase 1/3 clinical trial to evaluate efficacy and safety between a subcutaneous biosimilar of infliximab…
Two companies have announced that the European Medicines Agency (EMA) has accepted for regulatory review their Marketing Authorisation Applications (MAA) for proposed biosimilar candidates….
In another development in the ongoing dispute between Janssen against Celltrion and Hospira relating to infliximab, Janssen filed a new complaint on May 31, asserting infringement of U.S. Pat. No….
Pfizer, Inc. has filed two petitions (IPR2017-01488 and IPR2017-01489) challenging claims of U.S. Patent No. 6,407,213 (“the’213 patent”). According to the petitions, the ’213 patent…
Sources are reporting that Celltrion has received clearance from the China Food and Drug Administration (CFDA) to conduct clinical trials of Remsima (infliximab), a biosimilar of Janssen’s…
As we previously reported, Celltrion has moved to dismiss Janssen v. Celltrion for lack of standing. On Monday, Celltrion filed its reply brief in further support of that motion. The…
Below is our spring update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or…