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…
Yesterday, Biogen announced that the European Commission has granted marketing authorization for Imraldi® (also known as SB5). Imraldi® is a biosimilar for Humira® (adalimumab). Imraldi® is approved for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s…
On July 17, 2017, in the ongoing Amgen v. Sandoz litigation regarding Sandoz’s proposed biosimilar of Neulasta® (pegfilgrastim), the magistrate judge ordered, among other things, that Amgen is entitled to discovery from Sandoz regarding the anticipated approval, marketing, and sales of Sandoz’s proposed pegfilgrastim biosimilar. Sandoz argued that the discovery…
Sandoz has filed two petitions for IPR challenging Abbvie patents related to use of an antibody identified in the petitions as Humira® (adalimumab): IPR2017-01987 challenging U.S. Patent 8,911,737, directed to methods of treating Crohn’s disease, and IPR2017-01988 challenging U.S. Patent 8,974,790, directed to methods of treating ulcerative colitis. Sandoz’s petitions identify a…
Yesterday, Sandoz announced the launch of its etanercept product, Erelzi®, in Canada. Erelzi is a biosimilar to Amgen’s Enbrel®, and is approved for the treatment of moderately to severely active rheumatoid arthritis in adults with or without methotrexate and for reducing signs and symptoms of active ankylosing spondylitis. According to Sandoz, Erelzi® “is…
Samsung Bioepis announced that it has entered into a Strategic Collaboration Agreement with Takeda Pharmaceutical Company to co-develop novel biologic therapies in unmet disease areas. The companies’ first therapeutic candidate is intended to treat severe acute pancreatitis. According to the press release, diversifying into novel biologics development represents “a new chapter” for…
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) for those products. We also posted here that in July 2017, the French National Agency for Medicines and Health…