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…
As we previously reported last year, in the ongoing Janssen v. Celltrion litigation concerning Celltrion’s Inflectra®, a biosimilar of Janssen’s Remicade® (infliximab), Janssen appealed the district court’s partial final judgment of invalidity of Janssen’s ’471 patent based on a finding of obviousness-type double patenting. The Federal Circuit is treating that appeal as a companion case…
Today, Boehringer Ingelheim received FDA approval for Cyltezo®, its biosimilar to AbbVie’s Humira® (adalimumab). Cyltezo® is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. This is the second adalimumab biosimilar approved by the FDA. Amgen’s Amjevita® was the…
The Australian Federal Court recently ruled that to be eligible for an extension, a patent must cover a “product” rather than a “method of use.” AbbVie Biotechnology Ltd (AbbVie) filed requests to extend Australian patents 2012261708, 2013203420 and 2013257402, which cover methods of producing adalimumab using recombinant DNA technology. AbbVie…