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 for an expedited trial in view of a possible Celltrion launch in October of 2016. In a letter filed with the court yesterday, Janssen…
In a recent meeting, the FDA proposed modifications to the application review process for possible implementation into the Biosimilar User Fee Act (BsUFA). These modifications included establishing a review model similar to “the Program” initiated under the Prescription Drug User Fee Act (PDUFA). Highlights include a mid-cycle communication, a late-cycle…
IPR2016-00912 (Swiss Pharma Int’l AG) (U.S. Pat. No. 8,815,236) Petitioner: Swiss Pharma Int’l AG Patent: U.S. Patent No. 8,815,236 Patent Title: Method of Treating Multiple Sclerosis and Crohn’s Disease Patent Assignee: Biogen Idec MA, Inc. IPR2016-00915 (Swiss Pharma Int’l AG) (U.S. Pat. No. 8,349,321) Petitioner: Swiss Pharma Int’l AG Patent:…
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 The draft guidance provides FDA’s labeling recommendations for applicants seeking approval to market biosimilar products and applies only to non-interchangeable product. The draft guidance describes the FDA’s expectations about what information biosimilar manufacturers should include in their labels…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…
As we previously reported, AbbVie filed a citizen petition in December, asking the FDA to convene a Part 15 hearing on interchangeability determinations and to tighten the standards for that determination by, for example, requiring that all indications of the reference product be studied prior to granting an interchangeability designation,…
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…
A couple weeks ago, Oregon passed a law that allows pharmacists to automatically substitute a biosimilar for the reference branded biologic. According to this new legislation, before a biosimilar can be automatically substituted, it must be approved by the FDA as an “interchangeable” biosimilar, and the prescriber must not have…
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.
On April 1, Sanofi and Regeneron announced positive results in two placebo-controlled Phase 3 studies of dupilumab, a monoclonal antibody under evaluation for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis. According to Sanofi’s and Regeneron’s press release: “There are no approved systemic therapies in the U.S….