The European Medicines Agency (EMA) is planning to launch a pilot project aimed at testing the value of tailored scientific advice for the development of biosimilar medicines. Based on the analysis of analytical and functional data provided by the applicants, the EMA will provide recommendations on which tests/studies should be…
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization to Celltrion’s Truxima (rituximab), a biosimilar to Roche’s Mabtherba, which is indicated for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis. Truxima marks just the second recommended…
The Federal Circuit, over Celltrion’s opposition, has granted Janssen’s motion for a 30-day extension of time to file its opening appeal brief. Janssen’s opening brief is now due on January 26, 2017. Continue following Big Molecule Watch for more updates.
Eli Lilly and Boehringer Ingelheim announced today that their insulin glargine injection product, Basaglar® (a follow-on biologic for Sanofi’s Lantus®), is now available by prescription in the U.S. Although Basaglar is approved as a biosimilar for Lantus in Europe, in the U.S., Basaglar is not technically considered a biosimilar. In the U.S.,…
The European Crohn’s and Colitis Organisation (“ECCO”) released a statement last week supporting the switch from the reference infliximab to biosimilar infliximab in patients with inflammatory bowel disease (“IBD”). ECCO’s new position is particularly significant, given its earlier position taking a cautious approach to biosimilars and suggesting that “rigorous testing [of biosimilars]…
President Barack Obama will be joined today by Vice President Biden, House Energy and Commerce Committee Chairman Fred Upton (R-MI), and other Congressional leaders for the signing ceremony for the 21st Century Cures Act. The signing ceremony will take place at 2:30 pm ET. The bill signing will be live streamed here beginning…
Today, the Supreme Court denied certiorari in Apotex v. Amgen, a closely-watched case involving the interpretation of key provisions of the BPCIA. Our most recent blog coverage can be found here. Even though the Court has declined to hear Apotex v. Amgen, the Supreme Court has before it another vehicle for addressing the hotly-contested…
As we posted earlier this week, the Acting Solicitor General (“SG”), on December 7th, filed an amicus brief in which it (a) recommended that the Supreme Court grant Sandoz’s cert petition and Amgen’s conditional cross-cert petition regarding how to interpret important provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), and…
Health Canada, the federal regulatory authority that evaluates the safety, efficacy, and quality of drugs available in Canada recently released a revised Guidance Document on Information and Submission Requirements for Biosimilar Drugs (“Guidance”). The Biologics and Genetic Therapies Directorate (BGTD) within the Health Products and Food Branch of Health Canada is the…
This past April, the FDA approved Inflectra® (infliximab-dyyb), Celltrion and Hospira’s biosimilar of Janssen’s Remicade®. According to papers filed in the Federal Circuit this week, Celltrion and Hospira (collectively, “Celltrion”) have now launched Inflectra® in the United States. On December 6, Celltrion stated that it “recently launched in the United…