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…
The Acting Solicitor General has just filed an amicus brief recommending that Sandoz’s cert petition and Amgen’s cross-petition be granted. The Acting Solicitor General also argues that the decision by the Federal Circuit on the 180-day delay was incorrect. Amgen’s supplemental brief in response will be due December 21. The Court will…
In a 94-5 vote, the U.S. Senate today passed the 21st Century Cures Act (H.R.34). This vote comes just days after the House of Representatives voted in favor of the bill. The bill now heads to President Obama, who has been a vocal proponent of the bill and has stated…
The past few days have seen a lot of activity on the rituximab biosimilar front. According to a joint press release, Sanofi and JHL Biotech, a biopharmaceutical company based in China, formed an alliance to collaborate on the development and commercialization of a rituximab biosimilar and various pharmaceutical products in China….
Earlier this year, we reported that Mylan and Biocon submitted an aBLA for MYL-1401O, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab). Earlier this week, an article published in the Journal of the American Medical Association (JAMA), titled Effect of a Proposed Trastuzumab Biosimilar Compared With Trastuzumab on Overall Response Rate in Patients With ERBB2…
We recently reported that Amgen and Allergan had submitted an abbreviated Biologics License Application to the FDA for ABP 215, a biosimilar to Avastin® (bevacizumab). Today, the companies announced that they have also submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for this product. Stay tuned to Big…
The parties in Amgen v. Sandoz (N.D. Cal.) (filgrastim, pegfilgrastim) have submitted a joint stipulation to dismiss, without prejudice, Amgen’s U.S. Patent No. 5,824,784 patent from the litigation. The ‘784 patent is directed to certain N-terminally chemically modified protein compositions, as well as methods of treatment and manufacture. With dismissal…
Yesterday, we reported that the House of Representatives was set to vote on a revised draft of the 21st Century Cures Act. The Act was passed by a 392 to 26 vote and will now head to the Senate for a vote next week. Stay tuned to Big Molecule Watch…
In June last year, we outlined the key exclusivity provisions in the 21st Century Cures Act. Then in July 2015, we reported that the House of Representatives passed a form of the Act by a vote of 344-77. Although the Senate has received and read it twice, the Act was…