In the ongoing litigation over infliximab biosimilars, Janssen has filed two new complaints alleging infringement of claims in U.S. Patent No. 7,598,083: one against Celltrion and Hospira, and a…
In the ongoing litigation over infliximab biosimilars, Janssen has filed two new complaints alleging infringement of claims in U.S. Patent No. 7,598,083: one against Celltrion and Hospira, and a…
According to the Korea Pharmaceutical Manufacturers Association, the biosimilars market in South Korea will grow to 150 billion won (~$130 million) by 2019, nearly doubling in size from its…
We previously reported that the FDA approved Celltrion’s Inflectra®, a biosimilar to Janssen’s Remicade® (infliximab) on April 5, 2016. A year prior to the approval, Janssen filed a motion…
Samsung Bioepis Co., Ltd., announced that the FDA has accepted its first biosimilar application submitted in the United States. The candidate, SB2, references Janssen’s Remicade® (infliximab),…
The District Court for the District of Massachusetts (Judge Wolf) yesterday decided two pending motions in Janssen v. Celltrion: Plaintiffs’ motion to stay litigation on the ‘471…
We previously reported that the FDA approved Celltrion’s Inflectra®, a biosimilar to Janssen’s Remicade® (infliximab). We also reported on a series of letters concerning Janssen’s request…
Last month, the FDA released draft industry guidance on Labeling for Biosimilar Products. The draft guidance provides FDA’s labeling recommendations for applicants seeking approval to…
We previously reported that the FDA approved Celltrion’s Inflectra®, a biosimilar to Janssen’s Remicade® (infliximab). Last week, we also reported that in Janssen v. Celltrion, Janssen…
One week ago, we reported that FDA approved Celltrion’s Inflectra, a biosimilar to Janssen’s Remicade (infliximab). Today, Janssen filed a letter to the court in Janssen v. Celltrion informing…
FDA today approved Celltrion’s Inflectra, a biosimilar to Janssen’s Remicade (infliximab). This is the second biosimilar to be approved by FDA under the new BPCIA regime. For more information,…