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…
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…
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…
About 12 months ago, AbbVie filed a Citizen Petition asking the FDA to take certain steps to tighten and clarify its procedures for making interchangeability determinations. Earlier this year, both Sandoz and GPhA urged the FDA to deny the petition. Today, the FDA posted an interim response on the docket (FDA-2015-P-4935)…
Today, Pfizer reported that their trastuzumab biosimilar to Roche’s Herceptin® has shown equivalence in a Phase 3 clinical trial measuring objective response rate (ORR) when taken in combination with paclitaxel to treat HER-positive metastatic breast cancer patients. Pfizer also reported success in a separate study, REFLECTIONS B3271004, evaluating this biosimilar in early…