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 The draft guidance provides FDA’s labeling recommendations for applicants seeking approval to market biosimilar products and applies only to non-interchangeable product. The draft guidance describes the FDA’s expectations about what information biosimilar manufacturers should include in their labels…
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 filed a letter to the court stating that the “Defendants notified us that they intend to begin commercial sales of their biosimilar in no later than 180 days…
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 the court that the “Defendants notified us that they intend to begin commercial sales of their biosimilar in no later than 180 days…
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, see FDA’s press release on the approval, here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm.