According to press releases this week, the FDA has recently accepted two new Abbreviated Biologics License Applications (aBLA) for review. First, Adello Biologics yesterday announced that the FDA has accepted its aBLA for its proposed biosimilar of Neupogen® (filgrastim), which is indicated for, among other things, the treatment of neutropenia-related…
Yesterday, in the remanded appeal in Amgen v. Sandoz, the United States submitted an amicus brief to the Federal Circuit that generally supports the position taken by Sandoz and the Biosimilars Council that Amgen’s state-law claim for an injunction under California’s Unfair Competition Law (“UCL”) or tort damages to enforce compliance with…
With the September 18, 2017 trial date fast approaching, the district court in Amgen v. Hospira last week denied Hospira’s motion for summary judgment of non-infringement of its proposed biosimilar of Epogen®/Procrit® (epoetin alfa) and granted-in-part and denied-in-part the parties’ respective motions for exclusion of expert testimony. As we previously…
Last week Fresenius Kabi announced that it has successfully closed its acquisition of Merck KGaA’s biosimilars business, which comprises Merck’s entire biosimilars development pipeline. According to Fresenius, the product pipeline is focused on oncology and autoimmune diseases. Further information about the financial terms of the deal, which was originally announced in…
The Federal Circuit has scheduled the oral argument of Amgen’s appeal from the district court’s judgment of non-infringement of Apotex’s proposed biosimilars of Neupogen® (filgrastim) and Neulasta® (pegfilgrastim) for 2:00pm on October 3, 2017 at the Benjamin N. Cardozo School of Law Burns Moot Courtroom. As previously reported, the Federal…
As we’ve posted here, Biocon and Mylan are jointly developing a portfolio of biosimilars, including Fulphila (pegfilgrastim) and Ogivri (trastuzumab), and have filed applications for marketing authorization in the European Union (EU) and the United States for these products. In the EU, we posted that Biocon requested withdrawal and resubmission…
Below is our summer update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates (Summer 2016, Fall 2016, Midwinter 2017, Spring 2017).
Coherus reported that its proposed adalimumab (Humira) biosimilar candidate demonstrated clinical equivalence on all endpoints compared to the European marketed Humira. The candidate in this study also did not show any clinically meaningful difference in adverse events. These results came from the first of three ongoing pharmacokinetic bioequivalence studies. This study…
Samsung Bioepis has filed three petitions for IPR challenging Genentech patents related to the use of Herceptin® (trastuzumab): IPR2017-01958, challenging U.S. Patent 6,627,196; IPR2017-01959 challenging U.S. Patent 7,371,379; and IPR2017-01960 challenging U.S. Patent 7,892,549. Samsung Bioepis concurrently filed motions for joinder with Hospira’s petitions challenging the same patents (IPR2017-00804, IPR2017-00805, and…
As we previously reported, following the Supreme Court’s June 12, 2017 decision in Sandoz v. Amgen, the Federal Circuit on July 26, 2017, issued an order recalling its October 23, 2015 mandate, reinstating the appeal, and vacating its July 21, 2015 opinion. The Federal Circuit further ordered the parties to file “simultaneous…