Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2017: 1. Compared to three approvals in 2016, the FDA approved five…
Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2017: 1. Compared to three approvals in 2016, the FDA approved five…
Yesterday, Samsung Bioepis announced that the FDA has accepted for review the company’s BLA under the 351(k) pathway for SB3, a biosimilar candidate referencing Genentech’s…
On December 16, Celltrion announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Herzuma,…
Today, the FDA announced that it has approved Pfizer’s Ixifi® (infliximab-qbtx) as a biosimilar to Remicade®. Ixifi® is indicated for the treatment of most of the same conditions as…
Below are recent updates in biosimilar-related IPR proceedings: GENERAL BIOLOGICS PATENTS On December 1, 2017, the Board granted institution of four IPRs on Celltrion’s petitions (IPR2017-01373…
As we previously reported, Janssen and Samsung Bioepis jointly filed a stipulation of voluntary dismissal requesting that the District of New Jersey dismiss with prejudice Janssen’s patent…
Below is our fall update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our…
As we previously reported, the United States District Court for the District of Massachusetts denied Celltrion’s motion to dismiss for lack of standing in the Janssen v. Celltrion case. On…
On May 17, 2017, Janssen sued Samsung Bioepis in the District of New Jersey for patent infringement under the BPCIA based on Samsung Bioepis’s filing of its aBLA for Renflexis®…
The United States District Court for the District of Massachusetts has denied Celltrion’s motion to dismiss the action for lack of standing. As we previously reported, Celltrion argued…